CoverEdge Algorithm Programming Study

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Precision Spectra™ SCS system programming features

Study type: Interventional

Funder types: Industry

Identifiers

NCT02492880

91051317

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)