NCT06616025 This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
| NCT ID | NCT06616025 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Neuraptive Therapeutics Inc. |
| Condition | Peripheral Nerve Injury Upper Limb |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 98 participants in total. It began in 2025-02-10 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Seth Schulman, MD
STUDY DIRECTOR
Neuraptive Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT06616025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Nerve Injury Upper Limb. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06616025 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 98 participants.
Is NCT06616025 currently recruiting?
Yes, NCT06616025 is actively recruiting participants. Contact the research team at seth.schulman@neuraptive.com for enrollment information.
Where is the NCT06616025 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Orlando, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT06616025 clinical trial?
NCT06616025 is sponsored by Neuraptive Therapeutics Inc.. The principal investigator is Seth Schulman, MD at Neuraptive Therapeutics Inc.. The trial plans to enroll 98 participants.