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

Recruiting now · Not applicable

Conditions studied: Peripheral Nerve Injuries

In brief

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

Key facts

Study ID

NCT06529835

Run by

Auxilium Biotechnologies

People needed

80

Starts

2025-03-21

Expected to finish

2028-08-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UC San Diego Health — San Diego, California, United States (enrolling)
• UCSF Orthopedic Institute — San Francisco, California, United States (enrolling)
• Medstar Union Memorial Hospital- The Curtis National Hand Center — Baltimore, Maryland, United States (enrolling)
• NYU Langone Orthopedic Center — New York, New York, United States (enrolling)
• OSU Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
• UT Health Houston — Houston, Texas, United States (enrolling)
• The San Antonio Orthopaedic Group (TSAOG Orthopaedics) — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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