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

Launched by AUXILIUM BIOTECHNOLOGIES · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NeuroSpan Bridge to see how well it works for repairing damaged nerves in the arms and legs. Researchers want to compare this treatment to two other methods: the NeuraGen Nerve Guide and using a piece of the patient’s own nerve (called a nerve autograft). The goal is to help people who have experienced nerve injuries, which can happen from accidents or other causes.

To participate in the trial, you need to be between 18 and 80 years old and have a nerve injury in your arm or leg that has a gap of half a centimeter to three centimeters. The injury should be recent, occurring within the last three months, and you should not have a history of previous attempts to repair the same nerve. If you join the study, you will receive one of the three treatments, and your progress will be monitored by the researchers. This trial is still in the planning stages and has not started recruiting participants yet. If you think you might be eligible or have questions, it would be a good idea to talk to your doctor.

Gender

ALL

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