Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial (DELIVERY)

December 9, 2020 updated by: Abbott Medical Devices

Randomized, Controlled, Single Blind, Prospective, Multicenter Study Evaluating Anatomic Versus Targeted Lead Placement for BurstDR Therapy During the Trial Evaluation Period. (DELIVERY)

Prospective, multi-center, randomized, single blind study

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

This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:

Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period

If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.

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.
270

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

  • Australia
      • Frankston, Australia
        • Frankston Pain Management
      • Saint Leonards, Australia
        • North Shore Private Hospital
  • Austria
      • Graz, Austria
        • Hospital Elisabethinen GmbH
      • Vienna, Austria, 1160
        • Wilhelminenspital Wien
  • Germany
      • Duisburg, Germany, 47055
        • Sana Kliniken Duisburg Gm.bH
      • Düsseldorf, Germany
        • Medizinische Einrichtungen der Universität Düsseldorf
      • Gera, Germany
        • Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie
      • Nürnberg, Germany
        • Klinikum Nürnberg Süd
  • Italy
      • Pavia, Italy
        • Fondazione Salvatore Maugeri
  • Netherlands
      • Leiderdorp, Netherlands
        • Alrijne Ziekenhuis
      • Velp, Netherlands
        • Stichting Rijnstate Ziekenhuis - Velp
  • Sweden
      • Uppsala, Sweden
        • University Hospital
  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • Jason Edward Pope, MD
    • Florida
      • Clearwater, Florida, United States, 33765
        • Comprehensive Spine Institute
      • Merritt Island, Florida, United States, 32953
        • Florida Pain Institute
      • Winter Park, Florida, United States, 32789
        • National Pain Institute Winter Park
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Advanced Pain Care
      • Reno, Nevada, United States, 89511
        • Nevada Advanced Pain Specialists
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Tualatin, Oregon, United States, 97062
        • Spinal Diagnostics
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Tyler, Texas, United States, 75701
        • Precision Spine Care
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Hospital

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. Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
  2. Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
  3. Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
  4. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
  5. Patient is >18 years of age at the time of enrollment.
  6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
  7. Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

Exclusion Criteria:

  1. Patient currently has a spinal cord stimulation system implanted.
  2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
  3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
  4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
  5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

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.
ACTIVE_COMPARATOR: Group 1 (AB)
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Device: lead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
Other Names:
  • Spinal Cord Stimulation non-surgical Leads
  • Spinal Cord Stimulation Clinician Programmer
  • Spinal Cord Stimulation Patient Controller
ACTIVE_COMPARATOR: Group 2 (TB)
Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Device: lead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
Other Names:
  • Spinal Cord Stimulation non-surgical Leads
  • Spinal Cord Stimulation Clinician Programmer
  • Spinal Cord Stimulation Patient Controller

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
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period.

Qualification for permanent system implant was defined by a composite where all the following conditions were met:

  • ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation
  • Trial evaluation period lasted for a minimum of 3 days
  • Physician recommends subject for permanent system implant
  • Subject reports a willingness to pursue a permanent system implant

Subjects did not qualify for permanent system implant if they met both of the following:

  • < 50% PRP (patient reported pain relief) at the end of the trial evaluation
  • Trial evaluation period lasted for a minimum of 5 days
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

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
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation

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
Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
Time Frame: Trial system implant
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Trial system implant
Programming Time Needed for Each Randomized Group
Time Frame: Trial system implant
The programming time observed for both randomized groups
Trial system implant
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
Time Frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Rate of Serious Adverse Device Effects (SADE) Based on Randomization
Time Frame: From pre-implant to exit of the study, approximately 3 to 14 days
Rate of serious adverse device effects based on each randomized group.
From pre-implant to exit of the study, approximately 3 to 14 days
Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
Time Frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
Time Frame: Trial system implant
Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.
Trial system implant
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
Time Frame: Trial system implant
Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.
Trial system implant
Permanent System Qualification Rate at the End of Extended Trial Period
Time Frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.
From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation

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: Robyn Capobianco, PhD, Abbott

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.
September 22, 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.
August 23, 2018

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.
October 12, 2018

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).
September 4, 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.
September 6, 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.
September 11, 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.
January 5, 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.
December 9, 2020

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.
December 1, 2020

More Information

Terms related to this study

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-10116

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

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.

Clinical Trials on Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Clinical Trials on lead placement followed by BurstDR stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings