Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator (TRIUMPH)

July 7, 2021 updated by: Abbott Medical Devices
The TRIUMPH study is a post-market, international, multicenter, interventional, prospective, single-arm study intended to evaluate the sustainability of pain control and psychosocial and functional responses utilizing a multiple-waveform enabled neurostimulator in subjects with chronic, intractable pain of the trunk and/or limbs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TRIUMPH study will utilize the multiprogram trial stimulator or invisible trial system with BurstDR for the trial evaluation period and the Prodigy or Proclaim Elite family of neurostimulators with tonic or BurstDR waveform at permanent implant and follow-up for pain control and improvement of psychosocial function. The follow-up visits will be scheduled at 3, 6, 12, 18, and 24 months post permanent implant

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHA L'Enfant Jesus
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Finland
    • Eastern Finland
      • Kuopio, Eastern Finland, Finland, 70211
        • Kuopio University Hospital
  • Germany
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germany, 41460
        • Neurochirurgische Praxis Neuss
  • Italy
    • Lombardy
      • Milano, Lombardy, Italy, 20133
        • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Azienda Ospedaliero Univsitaria Pisana
  • Spain
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Andalusia
      • Sevilla, Andalusia, Spain, 41013
        • Hospital Virgin de Rocio
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
  • Switzerland
      • Morges, Switzerland, 1110
        • Ensemble Hospitalier de la Cote, Hopital de Morges
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85351
        • The Core Institute
      • Scottsdale, Arizona, United States, 85255
        • Tory McJunkin MD
      • Tucson, Arizona, United States, 85712
        • Pain Institute of Southern Arizona
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Chicago Anesthesia Associates, S.C.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Sports & Spine
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18951
        • St. Luke's Hospital & Health Network
      • Pottstown, Pennsylvania, United States, 19403
        • Performance Spine and Sports Physicians, P.C.
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
      • Greenville, South Carolina, United States, 29316
        • Carolinas Center for Advanced Management of Pain
    • Texas
      • Tyler, Texas, United States, 75701
        • Azalea Orthopedics
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53221
        • Advanced Pain Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
  2. Subject has a score of 6 or higher on the numeric rating scale (NRS) for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
  3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
  4. Subject is 18 years of age or older at the time of enrollment.
  5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
  6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.

Exclusion Criteria:

  1. Subject currently has a spinal cord stimulation system implanted.
  2. Subject has previously failed spinal cord stimulation (SCS) therapy (either trial system evaluation or permanent implant).
  3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
  4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
  5. Subject is currently participating in another clinical investigation with an active treatment arm.
  6. Subject unable to read and/or write.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: All enrolled subjects
All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG).
Device: Prodigy, Prodigy MRI or Proclaim Elite IPG
Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to 6 Months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to 6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Time Frame: Baseline to 6 Months
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Baseline to 6 Months
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline to 6 Months
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Baseline to 6 Months
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline to 6 Months
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Baseline to 6 Months
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Time Frame: Baseline to 6 Months
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Baseline to 6 Months
Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 6 Months
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Baseline to 6 Months
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Time Frame: Baseline to 6 Months
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Baseline to 6 Months
Mean Change in Physical Function From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
Time Frame: Baseline to 6 Months
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Baseline to 6 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Quality of Life From Baseline to 12 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Time Frame: Baseline to 12 Months
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Baseline to 12 Months
Mean Change in Quality of Life From Baseline to 18 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Time Frame: Baseline to 18 Months
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Baseline to 18 Months
Mean Change in Quality of Life From Baseline to 24 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire
Time Frame: Baseline to 24 Months
EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.
Baseline to 24 Months
Mean Change in Pain Catastrophizing From Baseline to 3 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline to 3 Months
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Baseline to 3 Months
Mean Change in Pain Catastrophizing From Baseline to 12 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline to 12 Months
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Baseline to 12 Months
Mean Change in Pain Catastrophizing From Baseline to 18 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline to 18 Months
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Baseline to 18 Months
Mean Change in Pain Catastrophizing From Baseline to 24 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS)
Time Frame: Baseline to 24 Months
The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.
Baseline to 24 Months
Mean Change in Anxiety From Baseline to 12 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline to 12 Months
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Baseline to 12 Months
Mean Change in Anxiety From Baseline to 18 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline to 18 Months
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Baseline to 18 Months
Mean Change in Anxiety From Baseline to 24 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline to 24 Months
The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.
Baseline to 24 Months
Mean Change in Depression From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Time Frame: Baseline to 12 Months
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Baseline to 12 Months
Mean Change in Depression From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Time Frame: Baseline to 18 Months
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Baseline to 18 Months
Mean Change in Depression From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9)
Time Frame: Baseline to 24 Months
The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).
Baseline to 24 Months
Mean Change in Fear Avoidance From Baseline to 3 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 3 Months
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Baseline to 3 Months
Mean Change in Fear Avoidance From Baseline to 12 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 12 Months
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Baseline to 12 Months
Mean Change in Fear Avoidance From Baseline to 18 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 18 Months
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Baseline to 18 Months
Mean Change in Fear Avoidance From Baseline to 24 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline to 24 Months
The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri & Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.
Baseline to 24 Months
Mean Change in Sleep From Baseline to 12 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Time Frame: Baseline to 12 Months
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Baseline to 12 Months
Mean Change in Sleep From Baseline to 18 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Time Frame: Baseline to 18 Months
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Baseline to 18 Months
Mean Change in Sleep From Baseline to 24 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale
Time Frame: Baseline to 24 Months
The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.
Baseline to 24 Months
Mean Change in Physical Function From Baseline to 12 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
Time Frame: Baseline to 12 Months
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Baseline to 12 Months
Mean Change in Physical Function From Baseline to 18 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
Time Frame: Baseline to 18 Months
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Baseline to 18 Months
Mean Change in Physical Function From Baseline to 24 Months Post-permanent Implant, Assessed by the Patient-Reported Outcome Measure Information System (PROMIS) Physical Function Scale
Time Frame: Baseline to 24 Months
The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.
Baseline to 24 Months
Mean Change in Pain From Baseline to End of Trial System (Post-permanent Implant), Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to end of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Mean Change in Pain From Baseline to 3 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to 3 Months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to 3 Months
Mean Change in Pain From Baseline to 12 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to 12 Months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to 12 Months
Mean Change in Pain From Baseline to 18 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to 18 Months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to 18 Months
Mean Change in Pain From Baseline to 24 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS)
Time Frame: Baseline to 24 Months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.
Baseline to 24 Months
Number of Participants With Patient Satisfaction at End of Trial System Evaluation
Time Frame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Patient satisfaction will be summarized by count and percentage of participants
End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Number of Participants With Patient Satisfaction at 3 Months
Time Frame: 3 Months
Patient satisfaction will be summarized by count and percentage of participants
3 Months
Number of Participants With Patient Satisfaction at 6 Months
Time Frame: 6 Months
Patient satisfaction will be summarized by count and percentage of participants
6 Months
Number of Participants With Patient Satisfaction at 12 Months
Time Frame: 12 Months
Patient satisfaction will be summarized by count and percentage of participants
12 Months
Number of Participants With Patient Satisfaction at 18 Months
Time Frame: 18 Months
Patient satisfaction will be summarized by count and percentage of participants
18 Months
Number of Participants With Patient Satisfaction at 24 Months
Time Frame: 24 Months
Patient satisfaction will be summarized by count and percentage of participants
24 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at the End of Trial System Evaluation
Time Frame: End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
End of trial system evaluation, approximately 5 to 7 days of BurstDR stimulation
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 3 Months
Time Frame: 3 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
3 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 6 Months
Time Frame: 6 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
6 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 12 Months
Time Frame: 12 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
12 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 18 Months
Time Frame: 18 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
18 Months
Rate of Global Improvement of the Patient by Using the Patient Global Impression of Change (PGIC) at 24 Months
Time Frame: 24 Months
The PGIC is a categorical rating scale used to evaluate the subject's impression of change in his/her condition since the beginning of the study treatment. The subject rates their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale via an interview technique. The categories are as follows: 1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better, and 7-a great deal better. Although this tool does not specify the area of change (e.g., pain, function, quality of life, etc.), it allows for an overall integrated assessment from the prospective of the subject. PGIC values of 6 or 7 are reported to correlate best with actual change.
24 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Time Frame: 3 Months
Medication usage measured as decrease in chronic pain related medication intake since baseline
3 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Time Frame: 6 Months
Medication usage measured as decrease in chronic pain related medication intake since baseline
6 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Time Frame: 12 Months
Medication usage measured as decrease in chronic pain related medication intake since baseline
12 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Time Frame: 18 Months
Medication usage measured as decrease in chronic pain related medication intake since baseline
18 Months
Rate of Medication Usage Measured as Number of Participants With Decrease in Chronic Pain Related Medication Intake Since Baseline
Time Frame: 24 Months
Medication usage measured as decrease in chronic pain related medication intake since baseline
24 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Time Frame: 3 months
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
3 months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Time Frame: 6 Months
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
6 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Time Frame: 12 Months
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
12 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Time Frame: 18 Months
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
18 Months
Number of Participants With Stimulation Sensation Assessed by Stimulation Assessment Form
Time Frame: 24 Months
The Stimulation Assessment Form includes questions to identify the sensations experienced when stimulation is used.
24 Months
Number of Patient Waveform Preference
Time Frame: 3 months
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
3 months
Number of Patient Waveform Preference
Time Frame: 6 months
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
6 months
Number of Patient Waveform Preference
Time Frame: 12 months
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
12 months
Number of Patient Waveform Preference
Time Frame: 18 months
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
18 months
Number of Patient Waveform Preference
Time Frame: 24 months
Participants could choose between two waveforms with different amplitude, pulse width and frequency to stimulate the spinal cord (burst or tonic). Patient waveform preference post-permanent implant is summarized by counts and percentages.
24 months
Recharging Activities- Number of Participants With Frequency of Recharge
Time Frame: 3 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
3 months
Recharging Activities- Number of Participants With Frequency of Recharge
Time Frame: 6 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
6 months
Recharging Activities- Number of Participants With Frequency of Recharge
Time Frame: 12 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
12 months
Recharging Activities- Number of Participants With Frequency of Recharge
Time Frame: 18 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants
18 months
Recharging Activities- Number of Participants With Frequency of Recharge
Time Frame: 24 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
24 months
Recharging Activities- Number of Participants With Duration of Recharge
Time Frame: 3 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
3 months
Recharging Activities- Number of Participants With Duration of Recharge
Time Frame: 6 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
6 months
Recharging Activities- Number of Participants With Duration of Recharge
Time Frame: 12 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
12 months
Recharging Activities- Number of Participants With Duration of Recharge
Time Frame: 18 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
18 months
Recharging Activities- Number of Participants With Duration of Recharge
Time Frame: 24 months
Recharging activities throughout the follow-up period for subjects who were implanted with a rechargeable device will be summarized by count and percentage of participants.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marie Fahey, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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