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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Bioness Inc
- Enrollment
- 62
- Locations
- 9
- Primary Endpoint
- Change in Pain from Screening through 6 Months
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Pain from Screening through 6 Months
Time Frame: Month 6
Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale
Secondary Outcomes
- 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)
- Pain medication use(Month 6)