A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes (COVERAGE)

November 18, 2020 updated by: Boston Scientific Corporation

COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes

The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • 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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Physicians Research Group, LLC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • PCPMG Clinical Research Unit, LLC
    • Texas
      • Rockwall, Texas, United States, 75032
        • Spine Team Texas

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets RELIEF Registry criteria for inclusion
  • Primary complaint of persistent or recurrent low back pain, with or without leg pain
  • Signed a valid, IRB/EC-approved informed consent form

Exclusion Criteria:

  • Meets any RELIEF Registry criteria for exclusion

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Programming, then Advanced Programming
Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.
Device: Conventional single source programming
Precision Spectra SCS System using conventional single source programming.
Device: Precision Spectra SCS System advanced programming
Precision Spectra SCS System using advanced programming
Active Comparator: Advanced Programming, then Conventional Programming
Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.
Device: Conventional single source programming
Precision Spectra SCS System using conventional single source programming.
Device: Precision Spectra SCS System advanced programming
Precision Spectra SCS System using advanced programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Paresthesia Coverage ≥50%
Time Frame: 7, 14 days post activation
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
7, 14 days post activation

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Kristen Lechleiter, M.S., Boston Scientific Neuromodulation Corporation

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

February 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90968587

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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