StimRouter Registry Clinical Protocol

Last updated: November 7, 2022
Sponsor: Bioness Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Neuropathy

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT03913689
CP-00001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is at least 18 years of age at the time of giving informed consent.
  2. Subject who has chronic pain of peripheral nerve origin
  3. Subject is eligible for StimRouter as determined by the Clinician.
  4. Subject has a score of 5 or higher on the Pain NRS for average pain specific to thearea(s) of chronic pain being treated over the past 24 hours
  5. Subject is planned to be scheduled for implant of StimRouter.
  6. Subject has a life expectancy greater than 6 months as determined by the Clinician.
  7. Subject who is able to read, understand, and voluntarily sign the IRB-approvedinformed consent form prior to the performance of any study-specific procedures.
  8. Subject who is able to understand and complete required assessments.

Exclusion

Exclusion Criteria:

  1. Subject has other concomitant treatment or medical condition that, in the opinion ofthe Clinician, prevents the subject from study participation.
  2. Subject who, for implantation in the trunk, has an implanted demand-type cardiacpacemaker or defibrillator.
  3. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve fieldStimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusionpump.
  4. Subject who has an implanted device in the area for StimRouter implantation withoutsponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) betweenthe StimRouter system and all other active implanted devices.
  5. Subject who requires, or is likely to require, diathermy at the implant site.
  6. Subject who requires, or is likely to require, therapeutic ultrasound at the implantsite.
  7. Subject who has a cancerous lesion present near the target stimulation point.
  8. Subject with a bleeding disorder, which, in the opinion of the investigator, is acontraindication to device placement.
  9. Subject who has an active systemic infection.
  10. Subject who is immunocompromised and/ or determined by the Clinician to be clinicallyinappropriate for the procedure and implant.
  11. Subject who has an active or existing skin disorder or irritation, which, at theClinician's discretion, precludes the use of skin gel electrodes.
  12. Subject who currently require or is likely to require Magnetic Resonance Imaging (MRI)within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm fromthe center of the MRI system's bore (the iso-center) and at least 16 cm outside of theMRI coil measured from the edge of the MRI coil.
  13. Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
  14. Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during thestudy period.
  15. Subject who is participating in any other study that could affect the outcome of theregistry, such as a spinal stimulation study.
  16. Subject who is in litigation related to their pain, or who has a pending or activeworker's compensation claim. (A patient receiving long-term medical care from asettled Worker-s Compensation claim would not be excluded.)
  17. Subject who declines to provide written consent or follow-up.

Study Design

Total Participants: 173
Study Start date:
June 26, 2019
Estimated Completion Date:
April 30, 2028

Study Description

This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 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 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.

Connect with a study center

  • University of California San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • California Orthopedics & Spine

    Larkspur, California 94939
    United States

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Stamford Hospital

    Stamford, Connecticut 06905
    United States

    Completed

  • International Spine,Pain and Performance Center

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Warner Orthopedics

    Baton Rouge, Louisiana 70817
    United States

    Active - Recruiting

  • Albert Einstein/Moss Rehab

    Elkins Park, Pennsylvania 19027
    United States

    Active - Recruiting

  • Valley Sports and Spine Clinic

    Blacksburg, Virginia 24060
    United States

    Active - Recruiting

  • Advocate Aurora Health

    Oshkosh, Wisconsin 54904
    United States

    Active - Recruiting

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