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ACTIVE NOT RECRUITING
NCT05870124
NA

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

Sponsor: Nalu Medical, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

185

Start Date

2023-04-27

Completion Date

2027-12-31

Last Updated

2026-03-04

Healthy Volunteers

No

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

Locations (17)

The Pain Institute of Southern Arizona

Tucson, Arizona, United States

Comprehensive Spine & Pain Physicians

Burbank, California, United States

Pain Management and Injury Relief

Thousand Oaks, California, United States

DBPS Research LLC

Denver, Colorado, United States

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, United States

Coastal Spine & Pain Center

Jacksonville, Florida, United States

University of Kansas Health System, Bell Hospital Marc A. Asher Comprehensive Spine Center

Kansas City, Kansas, United States

Insight Research Institute

Flint, Michigan, United States

NeuroInterventional Pain Management

Monroe, Michigan, United States

Michigan Neurology & Spine Center

Port Huron, Michigan, United States

Advanced Orthopedics and Sports Medicine Institute

Freehold, New Jersey, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Pacific Sports and Spine

Eugene, Oregon, United States

Columbia Pain Management

Milwaukie, Oregon, United States

Pain Specialists of America

Austin, Texas, United States

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Anesis Spine and Pain Care

Spokane, Washington, United States