CoverEdge Algorithm Programming Study

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.

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Key information

Conditions

Chronic Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barolat Neuroscience, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precision Spectra™ SCS system programming features

Device

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

Primary outcomes

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire

Time frame: minimum 25 days post IPG implant

Change in paresthesia distribution based on programming parameters

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jul 9, 2015
Registry last updated: Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed