CoverEdge Algorithm Programming Study



Status:Completed
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:July 20, 2015
End Date:February 21, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads

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.


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.
We found this trial at
1
site
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California 91355
Phone: 855-213-9890
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from
Valencia, CA
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