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
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
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
NCT ID
NCT02492880
First Posted
June 23, 2015
Last Updated
November 2, 2022
Sponsor
Boston Scientific Corporation
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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