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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying NTX-001 (PEG-Fusion) for people with peripheral nerve injury (pni) and peripheral nerve injury upper limb. The study is currently recruiting participants at 24 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(24)

Cedars Sinai Medical Center

Los Angeles, California, United States

Rothman Orthopedics - Advent Health

Orlando, Florida, United States

Orlando Health Orlando Regional Medical Center

Orlando, Florida, United States

Grady Health

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 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

The Cooper Health System

Camden, New Jersey, United States

NYU Langone Health

New York, New York, United States

UC Health

Cincinnati, Ohio, United States

University of Cincinnati Health

Cincinnati, Ohio, United States

The MetroHealth System

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pennsylvania, Department of Orthopaedic Surgery

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor, Scott and White Health

Dallas, Texas, United States

Texas Tech

Lubbock, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

UVA Health

Charlottesville, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06616025


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