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RECRUITING
NCT06616025
PHASE3

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

Sponsor: Neuraptive Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-02-10

Completion Date

2027-04-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

NTX-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