Recruiting

NeuroSpan Bridge, NeuraGen Nerve Guide, Nerve Autograft

Sponsor:

Auxilium Biotechnologies

Code:

NCT06529835

Conditions

Peripheral Nerve Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NeuroSpan Bridge

NeuroGen Nerve Guide

Nerve Autograft

Study Details

Brief summary:

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

Conditions

Peripheral Nerve Injuries

Study ID

NCT06529835

Start date

Mar 21, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NeuroGen Nerve Guide

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

active comparator: Nerve Autograft

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

Interventions

NeuroSpan Bridge

The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap.

The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump.

NeuroGen Nerve Guide

The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor.

Nerve Autograft

A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap

Primary outcome measure

  • Efficacy- Static two-point discrimination (s2PD) measured at 12 months. [ Time Frame: 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. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

UC San Diego Health

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Reid Abrams, MD

UCSF Orthopedic Institute

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Igor Immerman, M.D.

Medstar Union Memorial Hospital- The Curtis National Hand Center

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Principal Investigator:

Aviram Giladi

NYU Langone Orthopedic Center

Recruiting

New York, New York, United States, 10003

Contacts

Principal Investigator:

Jaques Hacquebord, M.D.

OSU Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Principal Investigator:

Amy Moore, M.D.

University of Pennsylvania- Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

David Bozentka, M.D.

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Jeffrey Trost, MD

The San Antonio Orthopaedic Group (TSAOG Orthopaedics)

Recruiting

San Antonio, Texas, United States, 78258

Contacts

Principal Investigator:

Mickey Cho, M.D.

More Information

Sponsor

Auxilium Biotechnologies

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Auxilium Biotechnologies on 2026-06-26.