CoverEdge Algorithm Programming Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-20

Study Completion Date

2017-02-21

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Precision Spectra™ SCS system programming features

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No