Evaluating NTX-001 for repairing upper extremity nerve injuries
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.
This study is testing a new surgical product called NTX-001 to see if it can help people with severe upper limb nerve injuries recover faster and better when used with standard stitching methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Neuraptive Therapeutics Inc. Industry-sponsored |
| Locations | 12 sites (Orlando, Florida and 11 other locations) |
| Trial ID | NCT06616025 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of NTX-001, a surgical product designed to enhance the repair of severed nerves in the upper extremities. The product is used alongside standard suture neurorrhaphy to potentially accelerate nerve function recovery. By facilitating PEG-fusion of axons, NTX-001 aims to reduce the degeneration-regeneration cycle, thereby minimizing atrophy and improving overall recovery outcomes for patients with significant nerve injuries. Participants will be monitored for their recovery progress over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with severe nerve transections requiring surgical intervention.
Not a fit: Patients whose nerve repair occurs more than 48 hours after injury or those requiring grafts or conduits may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and functional outcomes for patients with upper extremity nerve injuries.
How similar studies have performed: While similar approaches have been explored, the specific use of NTX-001 for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 involving an autograft, allograft or conduit(s). * Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair. * Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity. * The subject's injury is a result of a suicide attempt or self- harm. * The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system). * The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone. * The subject is pregnant or breastfeeding. * The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.
Where this trial is running
Orlando, Florida and 11 other locations
- Orlando Health Orlando Regional Medical Center — Orlando, Florida, United States (Recruiting)
- Grady Health — Atlanta, Georgia, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Curtis National Center at MedStar Union Memorial Hospital — Baltimore, Maryland, United States (Recruiting)
- Missouri Orthopaedic Institute — Columbia, Missouri, United States (Recruiting)
- Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St. — St Louis, Missouri, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
- University of Pennsylvania, Department of Orthopaedic Surgery — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- UVA Health — Charlottesville, Virginia, United States (Recruiting)
- Harborview Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Seth Schulman, MD
- Email: seth.schulman@neuraptive.com
- Phone: 215-206-9504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.