Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.
Neuraptive Therapeutics Inc.
Summary
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.
Description
NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even preven…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects whose nerve repair will occur greater than 48 hours after nerve transection. * Subjects requiring nerve repair involv…
Interventions
- Combination ProductNTX-001 (PEG-Fusion)
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.
Locations (12)
- Orlando Health Orlando Regional Medical CenterOrlando, Florida
- Grady HealthAtlanta, Georgia
- University of ChicagoChicago, Illinois
- Curtis National Center at MedStar Union Memorial HospitalBaltimore, Maryland
- Missouri Orthopaedic InstituteColumbia, Missouri
- Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.St Louis, Missouri