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NCT06616025PHASE3Recruiting

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

Neuraptive Therapeutics Inc.

Start Date

2/10/2025

Completion Date

4/30/2027

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.

Detailed Description

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

COMBINATION_PRODUCT

NTX-001 (PEG-Fusion)

Interested in This Trial?

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Conditions

Peripheral Nerve Injury Upper LimbPeripheral Nerve Injury (PNI)

Locations

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Rothman Orthopedics - Advent Health

Orlando, Florida 32804

United States

Orlando Health Orlando Regional Medical Center

Orlando, Florida 32806

United States

Grady Health

Atlanta, Georgia 30303

United States

University of Chicago

Chicago, Illinois 60637

United States

University of Louisville

Louisville, Kentucky 40202

United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana 70112

United States

Curtis National Center at MedStar Union Memorial Hospital

Baltimore, Maryland 21218

United States

Missouri Orthopaedic Institute

Columbia, Missouri 65211

United States

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

St Louis, Missouri 63110

United States

The Cooper Health System

Camden, New Jersey 08103

United States

NYU Langone Health

New York, New York 10003

United States

UC Health

Cincinnati, Ohio 45267

United States

University of Cincinnati Health

Cincinnati, Ohio 45267

United States

The MetroHealth System

Cleveland, Ohio 44109

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43212

United States

University of Pennsylvania, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania 19104

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Medical University of South Carolina

Charleston, South Carolina 29429

United States

Baylor, Scott and White Health

Dallas, Texas 75246

United States

Texas Tech

Lubbock, Texas 79415

United States

University of Utah Health

Salt Lake City, Utah 84132

United States

UVA Health

Charlottesville, Virginia 22903

United States

Harborview Medical Center

Seattle, Washington 98104

United States