RecruitingNot Applicable

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

United States80 participantsStarted 2025-03-21

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy- Static two-point discrimination (s2PD) measured at 12 months.

Timeframe: 12 months

Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.

Timeframe: 12 months

Trial details

NCT IDNCT06529835

SponsorAuxilium Biotechnologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Jacob Koffler, PhD, MBA

858-699-9443 j.koffler@auxiliumbio.com

View on ClinicalTrials.gov More Peripheral Nerve Injuries trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

What they're measuring

Efficacy- Static two-point discrimination (s2PD) measured at 12 months.

Timeframe: 12 months