CoverEdge Algorithm Programming Study

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT02492880

Run by

Boston Scientific Corporation

People needed

15

Starts

2015-07-20

Expected to finish

2017-02-21

Last updated by the study team

2022-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barolat Neuroscience — Denver, Colorado, United States
• Albany Medical Center — Albany, New York, United States

Full record on ClinicalTrials.gov

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