TARGET Post-Approval Study (TARGET PAS)

January 22, 2024 updated by: Abbott Medical Devices

TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II

The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

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

A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 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.
Observational

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.
426

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Pain Specialists
    • California
      • Camarillo, California, United States, 93010
        • Spanish Hills Interventional Pain Specialists
      • Larkspur, California, United States, 94939
        • California Orthopedics & Spine
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System
      • Loma Linda, California, United States, 92354
        • Loma Linda University Hospital
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
      • Santa Monica, California, United States, 90403
        • Orthopedic Pain Specialists
      • Santa Rosa, California, United States, 95401
        • Summit Pain Alliance Inc.
      • Santa Rosa, California, United States, 95403
        • Pacific Research Institute
    • Colorado
      • Fort Collins, Colorado, United States, 80525
        • Front Range Pain Medicine
    • Florida
      • Bradenton, Florida, United States, 34209
        • Coastal Orthopedics & Sports Medicine Southwest FL
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Gainesville, Florida, United States, 32610
        • University of Florida - Department of Anesthesia
      • Merritt Island, Florida, United States, 32953
        • Florida Pain Institute
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Better Health Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goodman Campbell Brain & Spine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Nura
      • Edina, Minnesota, United States, 55439
        • Twin Cities Pain Clinic
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Advanced Pain Care
      • Reno, Nevada, United States, 89511
        • Nevada Advanced Pain Specialists
    • New York
      • New York, New York, United States, 10022
        • Ainsworth Institute of Pain Management
      • Staten Island, New York, United States, 10305
        • The Spine & Pain Institute of New York
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Premier Pain Solutions
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Adena Bone and Joint Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Pacific Sports and Spine
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Tualatin, Oregon, United States, 97062
        • Spinal Diagnostics
    • Pennsylvania
      • Exton, Pennsylvania, United States, 19341
        • Center for Intervetional Pain and Spine
      • King Of Prussia, Pennsylvania, United States, 19406
        • Main Line Spine
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Department of Neurosurgery
      • Sewickley, Pennsylvania, United States, 15143
        • Pain Diagnostics and Interventional Care
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Carolinas Center for Advanced Management of Pain
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Vertex Spine and Pain
    • Texas
      • Killeen, Texas, United States, 76542
        • Central Texas Pain Institute
      • Mesquite, Texas, United States, 75150
        • Advanced Pain Solutions
      • San Angelo, Texas, United States, 76903
        • Shannon Clinic
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • The Spine and Nerve Center of St. Francis
    • 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

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subjects aged 22 to 75 with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II with a baseline VAS score of 6 or greater.

Description

Inclusion Criteria:

  • Subject is male or female between ≥ 22 and ≤ 75 years of age.
  • Subject has moderate to severe chronic intractable pain of the lower limbs resulting from Complex Regional Pain Syndrome (CRPS) types I or II.
  • Subject has a baseline Visual Analogue Scale (VAS) of ≥ 60 mm for overall pain at the time of the baseline assessment.
  • Subject is willing and able to comply with the study requirements.
  • Subject is able to provide written informed consent.

Exclusion Criteria:

  • Subject has an active implantable medical device including but not limited to cardiac pacemakers and cardiac defibrillators.
  • Subject is currently involved in medically related litigation, including workers compensation.
  • Subject has a life expectancy of less than one year.
  • Subject is pregnant or of child bearing potential and not using adequate contraception as determined by the investigator.
  • Subject has, or plans to have, a spinal cord stimulation system or infusion pump system implanted.
  • Subject has, or plans to have, a peripheral nerve stimulation system (PNS) or peripheral nerve field stimulation system (PNfS) implanted.
  • Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the implant procedure and/or recovery from the implant procedure or could complicate the required procedures and evaluations of the study in the judgment of the investigator.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Dorsal Root Ganglion (DRG) Stimulation
Device: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
Electrical stimulation of the DRG using the Axium™ Neurostimulator System
Device: Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.

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
Rate of Serious Adverse Events (SAEs)
Time Frame: throughout 12 month study
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
throughout 12 month study

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
Percent Change From Baseline to 12 Months Post-permanent Implant for Overall Pain Intensity Measured Using the Visual Analog Scale (VAS)
Time Frame: 12 months
The VAS is a common, self-administered measure in which subjects rate their pain intensity by marking a vertical line through a 100 mm horizontal line anchored by word descriptors on each end (no pain to worst imaginable pain). The distance between the beginning of the horizontal line and the vertical line is measured to produce a score between 0 and 100 mm (or 0 to 10 cm). A higher score indicates higher pain intensity and a 30% reduction in VAS score from baseline to follow-up is considered clinically relevant.
12 months
Change From Baseline to 12 Months Post-permanent Implant for Physical Function Measured Using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Physical Function Scale
Time Frame: 12 months
The PROMIS-29 Profile is an instrument made up of seven individual short forms (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference) that are scored individually. The instrument also includes a single pain intensity item which is reported as its raw score (e.g., 0 to 10). Each item has five response options ranging in value from 1 to 5, except for the Pain Intensity item which has eleven response options ranging in value from 0 to 10. A raw score is created from each short form that makes up the Profile. Raw scores are calculated by summing the values of the response to each question within each domain.
12 months
Change From Baseline to 12 Months Post-permanent Implant for Quality of Life Measured Using the PROMIS Global Health Scale
Time Frame: 12 months
The PROMIS Global Health short form is a validated, 10-item instrument designed to assess multiple health domains. The questionnaire yields a total score and sub-scale scores for Global Physical and Mental Health. Each question has potential five response options ranging in value from one to five to give a total score ranging from 10 to 50. All questions must be answered to arrive at a total score as one or more missing responses will render scores unusable. 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 global health.
12 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: Ann Jannu, PhD, CCRP, Abbott Neuromodulation

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.
August 23, 2016

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.
September 23, 2021

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.
September 23, 2021

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).
June 7, 2016

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.
June 14, 2016

First Posted (Estimated)

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.
June 15, 2016

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, 2024

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.
January 22, 2024

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.
January 1, 2024

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-10113

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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