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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.
Sponsor: Neuraptive Therapeutics Inc.
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
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