Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCheckpoint Surgical Inc.
About this trial
This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.
Eligibility criteria
Qualifiers
Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
Candidate for surgical intervention.
Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
Are age 18-80 years.
Disqualifiers
Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
Primary repair requiring graft >6cm.
Nerve reconstruction occurring >12 months post injury.
Age less than 18 or greater than 80 years.
Trial design
Treatments tested in this trial
- Checkpoint BEST System
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Checkpoint Surgical Inc.
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov