CompletedNot Applicable

CoverEdge Algorithm Programming Study

United States15 participantsStarted 2015-07-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire

Timeframe: minimum 25 days post IPG implant

Trial details

NCT IDNCT02492880

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-21

Results submitted2018-07-11

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