StimRouter Registry Clinical Protocol
a study on Pain
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.
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
This is a prospective, open-label, long-term, multi-center registry. Up to 1000 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 30 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 60 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 1 month post-implant, 3 months post-implant, 6 months post-implant, 12 months post-implant, and annually thereafter for the duration of the study. Specific assessments will be completed by the subject and clinician at these visits.
Chronic Pain StimRouter Neuromodulation System
You can join if…
Open to people ages 18 years and up
- Subject is at least 18 years of age at the time of giving informed consent.
- Subject is eligible for StimRouter as determined by the Clinician.
- 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 CAN'T join 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 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.
- University of California San Diego
accepting new patients
La Jolla California 92093 United States
- Stanford University
accepting new patients
Redwood City California 94063 United States
Lead Scientist at UCSD
- accepting new patients
- Start Date
- Completion Date
- Bioness Inc
- Study Type
- Last Updated
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