NCT05870124

Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT 2)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Nalu Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Detailed description

Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive: Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 36 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 36 months from randomization.

Conditions

• Peripheral Neuralgia
• Peripheral Neuropathy
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Nalu Neurostimulation System for PNS	The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
OTHER	Conventional Medical Management	Conventional Medical Management is the best standard of care treatment for the patient

Timeline

• Start date: 2023-04-27
• Primary completion: 2025-04-15
• Completion: 2027-12-31
• First posted: 2023-05-23
• Last updated: 2026-03-04

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study