N/A
Completed N=15
CoverEdge Algorithm Programming Study
Source: ClinicalTrials.gov NCT02492880 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire — 13; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire |
13; 0 | — |
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.
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. Informational only — not medical advice.