RecruitingNot ApplicableNCT06529835

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

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)

Sponsor

Auxilium Biotechnologies

Enrollment

80 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Nerve Injuries

Summary

This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Nerve Autograft, a medical device called NeuroGen Nerve Guide, and others for people with peripheral nerve injuries. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeuroSpan 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.

DEVICENeuroGen 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.

DEVICENerve 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