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

Recruiting now · Phase 3

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

In brief

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.

Key facts

Study ID

NCT06616025

Run by

Neuraptive Therapeutics Inc.

People needed

98

Starts

2025-02-10

Expected to finish

2027-04-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Harborview Medical Center — Seattle, Washington, United States (enrolling)
• Rothman Orthopedics - Advent Health — Orlando, Florida, United States (enrolling)
• Orlando Health Orlando Regional Medical Center — Orlando, Florida, United States (enrolling)
• Grady Health — Atlanta, Georgia, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
• Curtis National Center at MedStar Union Memorial Hospital — Baltimore, Maryland, United States (enrolling)
• Missouri Orthopaedic Institute — Columbia, Missouri, United States (enrolling)
• Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St. — St Louis, Missouri, United States (enrolling)
• The Cooper Health System — Camden, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• UC Health — Cincinnati, Ohio, United States (enrolling)
• University of Cincinnati Health — Cincinnati, Ohio, United States (enrolling)
• The MetroHealth System — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania, Department of Orthopaedic Surgery — Philadelphia, Pennsylvania, United States (enrolling)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Baylor, Scott and White Health — Dallas, Texas, United States (enrolling)
• Texas Tech — Lubbock, Texas, United States (enrolling)
• UVA Health — Charlottesville, Virginia, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of Utah Health — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.