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