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

Inclusion Criteria7

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 ≤3mm.
Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
Repair must take place within 3 months from injury
No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

Exclusion Criteria4

Previous history of nerve repair attempt at the treated nerve.
Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
Pregnancy or planning to become pregnant

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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