NCT06529835 A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
| NCT ID | NCT06529835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Auxilium Biotechnologies |
| Condition | Peripheral Nerve Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-03-21 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06529835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Nerve Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06529835 currently recruiting?
Yes, NCT06529835 is actively recruiting participants. Contact the research team at j.koffler@auxiliumbio.com for enrollment information.
Where is the NCT06529835 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, Baltimore, United States, New York, United States and 4 additional locations.
Who is sponsoring the NCT06529835 clinical trial?
NCT06529835 is sponsored by Auxilium Biotechnologies. The trial plans to enroll 80 participants.