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โ† Trials
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A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

RecruitingNAAges 18 Years - 80 YearsAllAuxilium Biotechnologies
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค3mm. 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: โ‰ค100mm 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: โ‰ค250mm 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
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What it tests

  • NeuroSpan Bridge
  • NeuroGen Nerve Guide
  • Nerve Autograft
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Where

8 sites
UC San Diego Health
San Diego, United States
UCSF Orthopedic Institute
San Francisco, United States
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, United States
NYU Langone Orthopedic Center
New York, United States
OSU Wexner Medical Center
Columbus, United States
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, United States
UT Health Houston
Houston, United States
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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