StimRouter Registry Clinical Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy

NCT01592344

Chronic Pain

COMPLETED NA

Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)

NCT05870124

Peripheral Neuralgia Peripheral Neuropathy Chronic Pain

ACTIVE_NOT_RECRUITING NA

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

NCT04238793

Neuropathic Pain From Lumbosacral Radiculopathy

COMPLETED PHASE1/PHASE2

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

NCT05287373

Peripheral Neuralgia Chronic Pain

ACTIVE_NOT_RECRUITING NA

A Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back Pain (CLBP)

NCT02393391

Chronic Low Back Pain

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

StimRouter Neuromodulation System

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

StimRouter Neuromodulation System

Intervention Type DEVICE

An implantable neuromodulation device that treats chronic peripheral nerve pain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

StimRouter Neuromodulation System

An implantable neuromodulation device that treats chronic peripheral nerve pain.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
11. Subject who has an active or existing skin disorder or irritation, which, at the Clinician'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 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.
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 the study period.
15. Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
16. 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.)
17. Subject who declines to provide written consent or follow-up.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes