This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

Conditions: Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI)

Summary

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.

Source: ClinicalTrials.gov (NCT06616025). StuddyBuddy aggregates publicly available trial information.