NCT04662320

Promoting Healing of Nerves Through Electrical Stimulation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Checkpoint Surgical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.

Detailed description

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.

Conditions

• Cubital Tunnel Syndrome
• Nerve Compression
• Nerve Injury
• Ulnar Neuropathies

Interventions

Type	Name	Description
DEVICE	Checkpoint BEST System	Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair. Other Name: Checkpoint BEST System

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-12-10
• Last updated: 2024-12-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study