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A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Sponsor: Auxilium Biotechnologies
Summary
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Official title: A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-03-21
Completion Date
2028-08
Last Updated
2025-11-10
Healthy Volunteers
No
Conditions
Interventions
NeuroSpan Bridge
The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump.
NeuroGen Nerve Guide
The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor.
Nerve Autograft
A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap
Locations (6)
UCSF Orthopedic Institute
San Francisco, California, United States
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, Maryland, United States
NYU Langone Orthopedic Center
New York, New York, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, Texas, United States