CoverEdge Algorithm Programming Study
Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
1 other identifier
interventional
15
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Jul 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedStudy Start
First participant enrolled
July 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2017
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedNovember 4, 2022
November 1, 2022
1.6 years
June 23, 2015
July 11, 2018
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
Change in paresthesia distribution based on programming parameters
minimum 25 days post IPG implant
Interventions
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Barolat Neuroscience
Denver, Colorado, 80218, United States
Albany Medical Center
Albany, New York, 12208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clincial Sciences
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Roshini Jain
Boston Scientific Neuromodulation Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
July 9, 2015
Study Start
July 20, 2015
Primary Completion
February 21, 2017
Study Completion
February 21, 2017
Last Updated
November 4, 2022
Results First Posted
August 7, 2018
Record last verified: 2022-11