This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used … (NCT06616025) | Clinical Trial Compass
RecruitingPhase 3
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
United States98 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 enrolle…
What they're measuring
1
Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain)