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Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
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 16 and 80 years of age.
Official title: Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.
Key Details
Gender
All
Age Range
12 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2020-09-25
Completion Date
2024-06-27
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
NTX-001
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.
Locations (10)
UF Health - University of FL - Gainesville
Gainesville, Florida, United States
Orlando Health
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
Curtis National Hand Center
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
The Ohio State University Wexner Medical Center Hand and Upper Extremity Center
Columbus, Ohio, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States