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CoverEdge Algorithm Programming Study

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision Spectra™ SCS system programming features
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring stimulation, implantable, pulse generator, back pain, chronic pain, leg pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
  • Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
  • Subject is 18 years of age or older when written informed consent is obtained.

Exclusion Criteria:

  • Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
  • Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

Sites / Locations

  • Barolat Neuroscience
  • Albany Medical Center

Outcomes

Primary Outcome Measures

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Change in paresthesia distribution based on programming parameters

Secondary Outcome Measures

Full Information

First Posted
June 23, 2015
Last Updated
November 2, 2022
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02492880
Brief Title
CoverEdge Algorithm Programming Study
Official Title
Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Precision Spectra™ SCS system programming features
Intervention Description
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
Primary Outcome Measure Information:
Title
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Description
Change in paresthesia distribution based on programming parameters
Time Frame
minimum 25 days post IPG implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU). Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. Subject is 18 years of age or older when written informed consent is obtained. Exclusion Criteria: Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU. Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Barolat Neuroscience
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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CoverEdge Algorithm Programming Study

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