MedTrace Logo

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

NCT05870124 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Nalu Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Martin · Nalu Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2025-04-15
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870124 on ClinicalTrials.gov