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.
Who can participate
Age range18 Years
SexALL
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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.