NCT05287373

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Nalu Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Conditions

• Peripheral Neuralgia
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Nalu Neurostimulation System for PNS	The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
OTHER	conventional medical management	Conventional medical management

Timeline

• Start date: 2022-02-23
• Primary completion: 2023-12-11
• Completion: 2026-09-30
• First posted: 2022-03-18
• Last updated: 2026-03-30

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study