StimRouter Registry Clinical Protocol

Completed

Conditions studied: Chronic Pain, Peripheral Neuropathy, Nervous System Diseases, Peripheral Nervous System Diseases, Peripheral Nervous System Problem, Peripheral Nerve Injuries, Peripheral Nervous

In brief

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.

Key facts

Study ID

NCT03913689

Run by

Bioness Inc

People needed

62

Starts

2019-06-26

Expected to finish

2024-06-30

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is at least 18 years of age at the time of giving informed consent.
• Subject who has chronic pain of peripheral nerve origin
• Subject is eligible for StimRouter as determined by the Clinician.
• 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
• Subject is planned to be scheduled for implant of StimRouter.
• Subject has a life expectancy greater than 6 months as determined by the Clinician.
• 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.
• Subject who is able to understand and complete required assessments.

You may not qualify if…

• Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
• Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
• 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.
• 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.
• Subject who requires, or is likely to require, diathermy at the implant site.
• Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
• Subject who has a cancerous lesion present near the target stimulation point.
• Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
• Subject who has an active systemic infection.
• Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
• Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
• 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 from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
• Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
• Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
• Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
• Subject who is in litigation related to their pain, or who has a pending or active worker's compensation claim. (A patient receiving long-term medical care from a settled Worker-s Compensation claim would not be excluded.)
• Subject who declines to provide written consent or follow-up.

Where it is running

• 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

Full record on ClinicalTrials.gov

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