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NCT06529835NARecruiting

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

Auxilium Biotechnologies

Start Date

3/21/2025

Completion Date

8/1/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: 1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm. 2. Nerve diameter at injury site ≤3mm. 3. 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. 4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm 6. Repair must take place within 3 months from injury 7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite) Exclusion Criteria: 1. Previous history of nerve repair attempt at the treated nerve. 2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy. 3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff. 4. Pregnancy or planning to become pregnant

Interventions

DEVICE

NeuroSpan Bridge

DEVICE

NeuroGen Nerve Guide

DEVICE

Nerve Autograft

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Conditions

Peripheral Nerve Injuries

Locations

UC San Diego Health

San Diego, California 92103

United States

UCSF Orthopedic Institute

San Francisco, California 94158

United States

Medstar Union Memorial Hospital- The Curtis National Hand Center

Baltimore, Maryland 21218

United States

NYU Langone Orthopedic Center

New York, New York 10003

United States

OSU Wexner Medical Center

Columbus, Ohio 43212

United States

University of Pennsylvania- Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104

United States

UT Health Houston

Houston, Texas 77030

United States

The San Antonio Orthopaedic Group (TSAOG Orthopaedics)

San Antonio, Texas 78258

United States