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

Active, not recruiting · Not applicable · NCT05870124

Conditions: Peripheral Neuralgia, Peripheral Neuropathy, Chronic Pain

At a glance

Research payments reported, 2025
$947,819
U.S. investigators named
17
Sites paid
21
Planned or actual enrollment
185

About the trial

Sponsor
Nalu Medical, Inc.
Tested
Nalu Neurostimulation System for PNS (device), Conventional Medical Management (other)
Dates
Started 2023-04-27; completion 2027-12-31
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2026-03-04. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Nalu Medical, Inc. reported $947,819 in research payments for this study in 2025 (135 payments).

Products named: Nalu Neurostimulation System

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Coastal Health Research $279,849
  • Research Source $95,105
  • Pain Institute of Southern Arizona $78,757
  • The Center for Clinical Research, LLC $68,700
  • Institute of Precision PAin Medicine $55,857
  • Dbps Research, LLC $54,184
  • Ku Medical Center Research Institute $46,414
  • Kimel PArk Surgery Center $42,800
  • Neurointerventional PAin Management $38,712
  • South Portland Surgical Center $31,050
  • Pain Management & Injury Relief $28,304
  • Surgical Institute of Monroe $27,300
  • International Spine PAin & Performance Center $18,236
  • Columbia PAin Management, PC $17,654
  • Thousand Oaks Surgery Center $17,500
  • Insight Research Institute $12,213
  • Pleasant View Surgery Center, LLC $8,500
  • Restore Health & PAin Treatment Group $7,320
  • Pacific Sports and Interventional Spine $6,720
  • Hightower Clinical Trial Services $6,550
  • Michigan Neurology & Spine Center $6,094

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.