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Recruiting NCT06529835

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

Conditions: Peripheral Nerve Injuries

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Auxilium Biotechnologies

Location: UC San Diego Health San Diego California

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06529835). StuddyBuddy aggregates publicly available trial information.