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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: Active NA study of Chronic Pain and Peripheral Neuropathy, sponsored by Nalu Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What the registry record for NCT05870124 still lists
NCT05870124 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (76% lower).
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 lists 17 locations in 12 states (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.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05870124's enrollment target sits among peer trials
185 91st of 301 higher than 211 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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