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NCT02492880 Clinical Trial

CoverEdge Algorithm Programming Study

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02492880
Other study ID # 91051317
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2015
Est. completion date February 21, 2017

Study information
Verified date November 2022
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 21, 2017
Est. primary completion date February 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Precision Spectra™ SCS system programming features
Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.

Locations
Country Name City State
United States Albany Medical Center Albany New York
United States Barolat Neuroscience Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire Change in paresthesia distribution based on programming parameters minimum 25 days post IPG implant
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