What is the Purpose of this Study?
This study focuses on people who have experienced a particular type of nerve injury involving a peripheral nerve in their fingers, hand or arm in which the nerve(s) has/have been completely severed, and the injury requires surgical repair. The study aims to determine the safety and effectiveness of an experimental surgical product called NTX-001 when used in nerve repair. Researchers also aim to learn whether the patient’s nerve becomes functional in a shorter period of time when compared to the usual treatment for nerve injuries. NTX-001 contains 3 solutions that are applied in consecutive order and timed steps to the severed nerve during surgical repair. The first solution/step will wash the nerve injury before the nerve is sewn together; the second solution/step is applied to the repaired nerve and will reduce the amount of solution that could come into contact with other areas of tissue. The 3rd solution or final step will be to wash the repaired nerve to remove the second solution, and the wound will then be closed. Participants will be randomly assigned to either the NTX-001 or Standard of Care group. The Standard of Care group will receive treatment that people usually have for this type of nerve injury. Other procedures include collection of vital signs and medical history, physical exam, blood tests, nerve stimulation test, electromyography, nerve conduction and sensory tests, muscle and sensory assessments, and questionnaires.
Eligibility
- * The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
- * The subject is between eighteen (18) and eighty (80) years of age.
- * The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair