StimRouter Registry Clinical Protocol

NCT03913689 | Completed FDA Device

• 1 other identifier: CP-00001
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chronic Pain; Peripheral Neuropathy; Nervous System Diseases; Peripheral Nervous System Diseases; Peripheral Nervous System Problem; Peripheral Nerve Injuries; Peripheral Nervous

Keywords

peripheral nerve stimuation (PNS)

Outcome Measures

Primary Outcomes (1)

• Change in Pain from Screening through 6 Months

  Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale

  Month 6

Secondary Outcomes (6)

• Change in Pain Severity post-implantation

  Month 6

• Change in Pain Interference post-implantation

  Month 6

• Change in Health-related Quality of Life

  MOnth 6

• Change in Patient Global Impression of change

  Month 6

• Patient Treatment Satisfaction

  Month 6

Other Outcomes (12)

• Change in average pain

  Month 12

• Change in average pain

  Month 24

• Change in Pain Severity

  Month 12

Study Arms (1)

StimRouter Neuromodulation System

Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin

Device: StimRouter Neuromodulation System

Interventions

StimRouter Neuromodulation System DEVICE

An implantable neuromodulation device that treats chronic peripheral nerve pain.

StimRouter Neuromodulation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 173 adult subjects (18 years or older) who have chronic pain of peripheral nerve origin, or other causes for which the Clinician determines StimRouter is the appropriate therapy.

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 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.)

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (9)

University of California San Diego

La Jolla, California, 92093, United States

Location

California Orthopedics & Spine

Larkspur, California, 94939, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Stamford Hospital

Stamford, Connecticut, 06905, United States

Location

International Spine,Pain and Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

Warner Orthopedics

Baton Rouge, Louisiana, 70817, United States

Location

Albert Einstein/Moss Rehab

Elkins Park, Pennsylvania, 19027, United States

Location

Valley Sports and Spine Clinic

Blacksburg, Virginia, 24060, United States

Location

Advocate Aurora Health

Oshkosh, Wisconsin, 54904, United States

Location

MeSH Terms

Conditions

Chronic Pain; Peripheral Nervous System Diseases; Nervous System Diseases; Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Keith McBride

  Bioness Inc

  STUDY CHAIR

• Eric Grigsby, MD

  Bioness Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 12, 2019
• Study Start: June 26, 2019
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)