N/A N=15 Basic Science

CoverEdge Algorithm Programming Study

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02492880 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire — 13; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Precision Spectra™ SCS system programming features (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire	13; 0	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02492880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.