NCT06867185NARecruiting
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
Checkpoint Surgical Inc.
Start Date
4/24/2025
Completion Date
3/1/2027
Summary
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
Eligibility Criteria
Age Range: 18 years to 80 years
Inclusion Criteria:
* Age 18-80 years
* Candidate for surgical intervention under general anesthesia.
* Require primary nerve injury repair in at least 1 digital nerve.
* Following resection, have a resulting nerve gap of ≤ 10mm.
* Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm
* Signed and dated informed consent form.
Exclusion Criteria:
* Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
* Nerve repair occurring \>1 month post-injury.
* Incomplete nerve transection.
* Injury requiring replantation of target digit
* Injury distal to the distal interphalangeal joint.
* Injury proximal to branching into the proper or common digital nerves.
* Injuries to both digital arteries of an affected digit.
* History of neuropathy, diabetic neuropathy, or any other known neuropathy
* History of chronic ischemic condition of the upper extremity
* Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.
Interventions
DEVICE
Brief Electrical Stimulation Therapy
PROCEDURE
Digital Nerve Repair
Conditions
Digital Nerve InjuryNerve InjuryNerve ReconstructionNerve TraumaDigital Nerve Lesion
Locations
Indiana Hand to Shoulder Center
Indianapolis, Indiana 46260
United States
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri 65212
United States
Washington University in St Louis, Department of Orthopedic Surgery
St Louis, Missouri 63110
United States
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio 43212
United States
Harborview Medical Center - University of Washington
Seattle, Washington 98104
United States