RecruitingPhase 3NCT06616025

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

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.


Sponsor

Neuraptive Therapeutics Inc.

Enrollment

98 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

COMBINATION_PRODUCTNTX-001 (PEG-Fusion)

One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy.


Locations(12)

Orlando Health Orlando Regional Medical Center

Orlando, Florida, United States

Grady Health

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Curtis National Center at MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Missouri Orthopaedic Institute

Columbia, Missouri, United States

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UVA Health

Charlottesville, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

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NCT06616025


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