NCT03913689

StimRouter Registry Clinical Protocol

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Bioness Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	StimRouter Neuromodulation System	An implantable neuromodulation device that treats chronic peripheral nerve pain.

Timeline

• Start date: 2019-06-26
• Primary completion: 2024-03-30
• Completion: 2024-06-30
• First posted: 2019-04-12
• Last updated: 2025-05-20

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study