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

NCT06616025

RecruitingPhase 3

Sponsor: Neuraptive Therapeutics Inc.

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

Interventions: NTX-001 (PEG-Fusion)

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (24)

Los Angeles, California, United States
Orlando, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Camden, New Jersey, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States