NeuroSpan Bridge vs NeuraGen vs Autograft for Peripheral Nerve Injury

(NeuroSpan-1 Trial)

Recruiting at 5 trial locations

Overseen By Jacob Koffler, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auxilium Biotechnologies

Disqualifiers: Diabetes, Peripheral neuropathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three treatments for repairing nerve injuries: NeuroSpan Bridge (a nerve repair device), NeuraGen Nerve Guide, and Nerve Autograft. The goal is to evaluate how effectively each treatment aids nerve healing in the arms or legs. Individuals with nerve injuries featuring gaps between 0.5 and 3.0 cm, and without major health issues affecting nerve healing, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for nerve repair.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the NeuroSpan Bridge aims to help repair nerve injuries, with a strong focus on safety. In earlier studies, researchers closely monitored potential issues, such as infections, swelling, redness, and long-lasting pain. They also checked for device-related problems, including the body rejecting the device.

Although the exact number of people who experienced these issues isn't provided, the emphasis on monitoring demonstrates a careful approach to safety. This means that while risks exist, researchers actively watch and manage them. Prospective trial participants can use this information to understand what to expect regarding safety checks and monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard options for peripheral nerve injuries, which typically involve nerve autografts or guides like the NeuraGen, the NeuroSpan Bridge offers a unique approach. This treatment stands out because it uses an innovative scaffold technology that aims to bridge nerve gaps and promote natural nerve regeneration without needing a graft from another part of the body. Researchers are excited about NeuroSpan Bridge because it could simplify the repair process and reduce complications associated with traditional grafts, potentially leading to faster recovery and improved nerve function.

What evidence suggests that this trial's treatments could be effective for peripheral nerve injury?

This trial will compare the NeuroSpan Bridge with the NeuraGen Nerve Guide and Nerve Autograft for peripheral nerve injury. Research has shown that the NeuroSpan Bridge could help repair damaged nerves. Tests in animals for nerve gaps up to 3 centimeters demonstrated better performance than current devices. The device aims to restore nerve function and reduce the risk of complications. Early results suggest it might be a good option for those needing nerve repair. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 who have a nerve injury in their arms or legs with a gap between the ends of the injured nerve that's less than an inch. The injury should be recent (within the last 3 months), and surgery shouldn't pose additional health risks like infection.

Inclusion Criteria

Nerve diameter at injury site ≤3mm

I am 18-80 years old with a nerve injury in my arm or leg that has a gap of 0.5 to 3.0 cm.

My nerve injury is in my arm or leg, from shoulder to wrist/hand or hip to ankle/foot.

Exclusion Criteria

Allergy to Bovine products such as Bovine Collagen Nerve Cuff

I have a condition like diabetes or previous nerve damage that affects nerve healing.

Pregnancy or planning to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures for nerve repair using either NeuroSpan Bridge, NeuraGen Nerve Guide, or Nerve Autograft

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of motor and sensory function, pain, and complications

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• NeuroSpan Bridge

Trial Overview The study compares three methods of repairing nerves: NeuroGen Nerve Guide, NeuroSpan Bridge, and traditional Nerve Autograft. Participants will be randomly assigned to one method without knowing which they receive, and results are evaluated by someone unaware of the method used.

How Is the Trial Designed?

Group I: Nerve Autograft Active Control 2 Interventions

The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.

Group II: NeuroGen Nerve Guide Active Control 2 Interventions

The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.

Who Is Running the Clinical Trial?

Auxilium Biotechnologies

Lead Sponsor

Trials

1

Recruited

80+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11009477

The Neurospan Bridge: A Device for Peripheral Nerve Repair It has been extensively tested in gaps up to 3cm-long and demonstrated superiority to existing devices in a short-gap animal model, and superiority to nerve ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06529835

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

3. druganddeviceworld.com druganddeviceworld.com/2025/05/22/auxilium-trials-nerve-regeneration-neurospan-bridge-device/

Auxilium trials nerve regeneration NeuroSpan Bridge device The NeuroSpan Bridge device is designed to potentially restore nerve function and reduce complications in patients with nerve injuries.

4. withpower.com withpower.com/trial/phase-peripheral-nerve-injuries-8-2024-a912e

NeuroSpan Bridge vs NeuraGen vs Autograft for Peripheral ... This trial is for adults aged 18 to 80 who have a nerve injury in their arms or legs with a gap between the ends of the injured nerve that's less than an inch.

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06529835

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

6. trial.medpath.com trial.medpath.com/clinical-trial/b5df94a2cb1275c1/nct06529835-comparison-neurospan-neruagen-nerve-autograft-peripheral-nerve-repair

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide ... Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions ...