Actively Recruiting
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Led by Auxilium Biotechnologies · Updated on 2025-11-10
80
Participants Needed
6
Research Sites
175 weeks
Total Duration
On this page
Sponsors
A
Auxilium Biotechnologies
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
CONDITIONS
Official Title
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm
- Nerve diameter at injury site is 3 mm or less
- Nerve injury located in the arm from shoulder to wrist including the hand, or leg from hip to ankle including the foot
- For motor nerve injuries: distance from injury to nearest innervated muscle is 100 mm or less
- For sensory and mixed nerve injuries: distance from injury to nearest sensory nerve target is 250 mm or less
- Repair must be done within 3 months of injury
- No contraindications to surgical repair such as risk of infection or dog bite
You will not qualify if you...
- Previous nerve repair attempt on the treated nerve
- Diseases that reduce nerve regeneration such as diabetes, non-traumatic peripheral neuropathy, chemotherapy treatment, or other peripheral neuropathies
- Allergy to bovine products like bovine collagen nerve cuff
- Pregnancy or planning to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
UCSF Orthopedic Institute
San Francisco, California, United States, 94158
Actively Recruiting
2
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, Maryland, United States, 21218
Actively Recruiting
3
NYU Langone Orthopedic Center
New York, New York, United States, 10003
Actively Recruiting
4
OSU Wexner Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
5
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, Texas, United States, 78258
Actively Recruiting
Research Team
J
Jacob Koffler, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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