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RECRUITING
NCT06529835
NA

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

Sponsor: Auxilium Biotechnologies

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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