StimRouter Registry Clinical Protocol

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.