Actively Recruiting
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
Led by Neuraptive Therapeutics Inc. · Updated on 2026-04-16
98
Participants Needed
12
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has voluntarily agreed and signed informed consent
- Subject is between 18 and 80 years old
- Subject has clinical evidence of Sunderland's 4th or 5th degree nerve transection causing upper extremity nerve impairment requiring surgery
You will not qualify if you...
- Nerve repair will occur more than 48 hours after transection
- Nerve repair involves autograft, allograft, or conduit(s)
- Multiple nerve injuries only if not all are amenable to direct repair
- Investigator judges unlikely meaningful recovery due to muscle atrophy or morbidity
- Injury caused by suicide attempt or self-harm
- History or signs of conditions affecting nerve or vascular growth/physiology
- Known allergy to polyethylene glycol (PEG) or human grade silicone
- Pregnant or breastfeeding
- Currently enrolled or participated in another investigational study within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Actively Recruiting
2
Grady Health
Atlanta, Georgia, United States, 30303
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Curtis National Center at MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
5
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65211
Actively Recruiting
6
Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.
St Louis, Missouri, United States, 63110
Actively Recruiting
7
NYU Langone Health
New York, New York, United States, 10003
Actively Recruiting
8
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
9
University of Pennsylvania, Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29429
Actively Recruiting
11
UVA Health
Charlottesville, Virginia, United States, 22903
Actively Recruiting
12
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
S
Seth Schulman, MD
CONTACT
K
Kristen Olszyk, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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