NeuroSpan Bridge vs NeuraGen vs Autograft for Peripheral Nerve Injury

(NeuroSpan-1 Trial)

Recruiting at 4 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

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+