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StimRouter Registry Clinical Protocol

A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness? StimRouter? Neuromodulation System in Subjects with Chronic Pain of Peripheral Nerve Origin (Bioness CP-00001)

Study Details
This is a prospective, open-label, long-term, multi-center registry. Up to 1000 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 30 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 60 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 1 month post-implant, 3 months post-implant, 6 months post-implant, 12 months post-implant, and annually thereafter for the duration of the study. Specific assessments will be completed by the subject and clinician at these visits.
ClinicalTrials.gov Identifier:
NCT03913689
Principal Investigator(s)
Ofer Wellisch, MD
Sponsor(s)
Bioness Inc.
Contact
Maryanne Ducey, DC, RN at 203-358-8879
or officeofresearch@stamhealth.org

Location

  • Stamford Health Tully Health Center
    32 Strawberry Hill Court
    Stamford, CT 06902
    Main: 203-276-2000

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