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StimRouter Registry Clinical Protocol | Clinical Trials | Clareo Health

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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

NCT03913689•Bioness Inc

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 the area(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-approved informed consent form prior to the performance of any study-specific procedures.
•8. Subject who is able to understand and complete required assessments.

Exclusion Criteria

•1. Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
•2. Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
•3. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
•4. Subject who has an implanted device in the area for StimRouter implantation without sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the 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 implant site.
•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 a contraindication to device placement.
•9. Subject who has an active systemic infection.
•10. Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
+7 more criteria

Locations (9)

University of California San Diego

La Jolla, California, United States

California Orthopedics & Spine

Larkspur, California, United States

Stanford University

Redwood City, California, United States

Stamford Hospital

Stamford, Connecticut, United States

International Spine,Pain and Performance Center

Washington D.C., District of Columbia, United States

Warner Orthopedics

Baton Rouge, Louisiana, United States

Albert Einstein/Moss Rehab

Elkins Park, Pennsylvania, United States

Valley Sports and Spine Clinic

Blacksburg, Virginia, United States

Advocate Aurora Health

Oshkosh, Wisconsin, United States

Key Dates

Start Date

June 26, 2019

Primary Completion Date

March 30, 2024

Completion Date

June 30, 2024

Last Updated

May 20, 2025

Enrollment

ACTUAL participants

Conditions

Chronic PainPeripheral NeuropathyNervous System DiseasesPeripheral Nervous System DiseasesPeripheral Nervous System ProblemPeripheral Nerve InjuriesPeripheral Nervous

Interventions

StimRouter Neuromodulation System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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StimRouter Registry Clinical Protocol

Inclusion Criteria

Exclusion Criteria

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