RecruitingNot ApplicableNCT06867185

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

Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves

Sponsor

Checkpoint Surgical Inc.

Enrollment

60 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Nerve Injury Digital Nerve Injury Nerve Reconstruction Nerve Trauma Digital Nerve Lesion

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria10

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.

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