Status:
RECRUITING
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Lead Sponsor:
Auxilium Biotechnologies
Collaborating Sponsors:
MCRA
Conditions:
Peripheral Nerve Injuries
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06529835
Start Date
March 21 2025
End Date
August 1 2028
Last Update
November 7 2025
Active Locations (6)
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1
UCSF Orthopedic Institute
San Francisco, California, United States, 94158
2
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, Maryland, United States, 21218
3
NYU Langone Orthopedic Center
New York, New York, United States, 10003
4
OSU Wexner Medical Center
Columbus, Ohio, United States, 43212