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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.

RecruitingPhase 3

Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.

Who can join

Ages 18 to 80 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Neuraptive Therapeutics Inc. · Participants: 98 · Started: Feb 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06616025

Locations in the U.S.

CaliforniaCedars Sinai Medical Center, Los Angeles (Not yet recruiting)
FloridaOrlando Health Orlando Regional Medical Center, Orlando
Rothman Orthopedics - Advent Health, Orlando
GeorgiaGrady Health, Atlanta
IllinoisUniversity of Chicago, Chicago
KentuckyUniversity of Louisville, Louisville
LouisianaLouisiana State University Health Sciences Center, New Orleans
MarylandCurtis National Center at MedStar Union Memorial Hospital, Baltimore
MissouriMissouri Orthopaedic Institute, Columbia
Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St., St Louis
New JerseyThe Cooper Health System, Camden
New YorkNYU Langone Health, New York
OhioUC Health, Cincinnati
University of Cincinnati Health, Cincinnati
The MetroHealth System, Cleveland
The Ohio State University Wexner Medical Center, Columbus
PennsylvaniaUniversity of Pennsylvania, Department of Orthopaedic Surgery, Philadelphia
Allegheny Health Network, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TexasBaylor, Scott and White Health, Dallas
Texas Tech, Lubbock
UtahUniversity of Utah Health, Salt Lake City (Not yet recruiting)
VirginiaUVA Health, Charlottesville
WashingtonHarborview Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.