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
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