Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
NCT05287373 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89
Last updated 2026-03-30
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
- DEVICE
-
Nalu Neurostimulation System for PNS
The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
- OTHER
-
conventional medical management
Conventional medical management
Sponsors & Collaborators
-
Nalu Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Patrick Martin · Nalu Medical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-23
- Primary Completion
- 2023-12-11
- Completion
- 2026-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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