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Clinical Trials in the USA / NCT04662320
Active, not recruiting Not applicable

Promoting Healing of Nerves Through Electrical Stimulation

NCT04662320 · tracked via the Priya Life Science USA tracker
Sponsor
Checkpoint Surgical Inc
Phase
Not applicable
Started
2021-09-01
Last updated
2024-12-05

Condition(s) studied

Cubital Tunnel SyndromeNerve CompressionNerve InjuryUlnar Neuropathies

Investigational drug(s) / intervention(s)

Checkpoint BEST System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Electrodiagnostic evidence of ulnar neuropathy at the elbow. * Are candidates for surgical intervention. * Evidence of motor involvement such as intrinsic muscle atrophy or weakness. * Are age 18-80 years. * Signed and dated informed consent form. Exclusion Criteria: * Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery * Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury * Global peripheral neuropathy affecting the hands * Age less than 18 or greater than 80 years * Un-affected hand maximum grip strength \<12kg

Primary outcome measure(s)

  • Change in Grip Strength at 1 year. — 1 year
    Change in grip strength at 1 year from baseline (pre-operative) assessment.

Trial sites (5)

FacilityCityRegionStatus
Stanford University Stanford California
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery Chicago Illinois
Washington University in St. Louis St Louis Missouri
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery Columbus Ohio
Medical College of Wisconsin - Hand Center Milwaukee Wisconsin

More Checkpoint Surgical Inc. trials in the USA

Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries Recruiting

Other trials for the same condition

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation Recruiting
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04662320 on ClinicalTrials.gov ↗ ← All trials in the USA