Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
Launched by CHECKPOINT SURGICAL INC. · Mar 4, 2025
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using electrical stimulation during surgery can help nerves heal faster after a digital nerve injury. Digital nerves are the nerves that run along your fingers and hands, and injuries to these nerves can cause pain, numbness, or difficulty moving your fingers. The researchers want to see if stimulating the nerve with electricity while repairing it can improve healing and recovery.
To participate in this study, you need to be between 18 and 80 years old and be scheduled for surgery to repair a digital nerve injury. You should have a specific type of nerve injury that meets certain criteria, like having a nerve gap of 10mm or less. However, if you have serious health conditions that could complicate surgery, or if your injury doesn't meet the study's requirements, you may not be eligible. If you join the trial, you’ll receive information about what to expect during the study, and your progress will be closely monitored to ensure your safety and well-being.
Gender
ALL
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
- • Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.
About Checkpoint Surgical Inc.
Checkpoint Surgical Inc. is a pioneering medical device company specializing in advanced neuromodulation technologies aimed at improving surgical outcomes and enhancing patient recovery. With a commitment to innovation, Checkpoint Surgical develops cutting-edge solutions that facilitate nerve identification and preservation during surgical procedures, ultimately reducing complications and enhancing overall patient care. The company's dedication to rigorous clinical research and collaboration with healthcare professionals underscores its mission to transform surgical practices and improve the quality of life for patients. Through its initiatives, Checkpoint Surgical is at the forefront of advancing surgical techniques and fostering better health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
St. Louis, Missouri, United States
Columbia, Missouri, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported