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NCT05870124 · ClinicalTrials.gov registry record · NA

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

A NA study of Chronic Pain and Peripheral Neuropathy, sponsored by Nalu Medical.

Active
Registry status
NA
Development phase
185
Enrollment target
17
Study locations

NCT05870124 is a NA study of Chronic Pain and Peripheral Neuropathy that is active but no longer recruiting, run by Nalu Medical. The registered enrollment target is 185 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 12 states.

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The verdict

NCT05870124, a NA study of Chronic Pain and Peripheral Neuropathy, is active but no longer recruiting, sponsored by Nalu Medical.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
185 participants
Enrollment target
17
Study locations

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.

Interventions

  • DEVICE Nalu Neurostimulation System for PNS
  • OTHER Conventional Medical Management

Study Locations (17)

Michigan

  • Insight Research Institute - Flint
  • NeuroInterventional Pain Management - Monroe
  • Michigan Neurology & Spine Center - Port Huron

California

  • Comprehensive Spine & Pain Physicians - Burbank
  • Pain Management and Injury Relief - Thousand Oaks

Oregon

  • Pacific Sports and Spine - Eugene
  • Columbia Pain Management - Milwaukie

Texas

  • Pain Specialists of America - Austin
  • Institute of Precision Pain Medicine - Corpus Christi

Arizona

  • The Pain Institute of Southern Arizona - Tucson

Colorado

  • DBPS Research LLC - Denver

District of Columbia

  • International Spine, Pain & Performance Center - Washington D.C.

Florida

  • Coastal Spine & Pain Center - Jacksonville

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 2023-04-27
Est. Completion 2027-12-31
Phase NA

Sponsor

Nalu Medical

3 total trials

What the Registry Record Tells You About NCT05870124

The ClinicalTrials.gov registry entry for NCT05870124 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (76% lower). The listed sponsor is Nalu Medical, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions - of which Nalu Neurostimulation System for PNS is the first listed.

NCT05870124 reports 17 study locations spanning 12 distinct geographic areas - top geographies include Michigan, California, Oregon.

Frequently Asked Questions

What is clinical trial NCT05870124 about?

NCT05870124 is a clinical study titled "Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)". 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 postsurg...

What is the current status of trial NCT05870124?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 185 participants. The study started on 2023-04-27. Estimated completion is 2027-12-31.

What conditions does trial NCT05870124 study?

This clinical trial studies the following conditions: Chronic Pain, Peripheral Neuropathy, Peripheral Neuralgia.

What interventions are being tested in trial NCT05870124?

The interventions under investigation include: Nalu Neurostimulation System for PNS (DEVICE), Conventional Medical Management (OTHER).

Who is sponsoring clinical trial NCT05870124?

This trial is sponsored by Nalu Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05870124 being conducted?

This trial has 17 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.