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Recruiting NCT06867185

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

Trial Parameters

Condition Digital Nerve Injury
Sponsor Checkpoint Surgical Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-04-24
Completion 2027-01
Interventions
Brief Electrical Stimulation TherapyDigital Nerve Repair

Brief 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

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 * Cogn

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