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

NCT06529835 | Recruiting FDA Device

• 1 other identifier: AUX-NS-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (2)

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

  This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 12 months.

  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.

  This endpoint will examine 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.

  12 months

Secondary Outcomes (6)

• Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.

  12 months

• Sensory function assessed by the British Medical Research Council grading system at 12 months.

  12 months

• Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.

  12 months

• The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.

  12 months

• The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.

  12 months

Other Outcomes (4)

• Decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.

  12 months

• Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.

  12 months

• Changes in Numerical Rating Scale (NRS) pain scores from baseline.

  12 months

Study Arms (2)

NeuroGen Nerve Guide

ACTIVE COMPARATOR

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

Device: NeuroSpan Bridge; Device: NeuroGen Nerve Guide

Nerve Autograft

ACTIVE COMPARATOR

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

Device: NeuroSpan Bridge; Device: Nerve Autograft

Interventions

NeuroSpan Bridge DEVICE

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.

Nerve Autograft; NeuroGen Nerve Guide

NeuroGen Nerve Guide DEVICE

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.

NeuroGen Nerve Guide

Nerve Autograft DEVICE

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

Nerve Autograft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Pregnancy or planning to become pregnant

Sponsors & Collaborators

• Auxilium Biotechnologies: lead
• MCRA: collaborator

Study Sites (6)

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

RECRUITING

Medstar Union Memorial Hospital- The Curtis National Hand Center

Baltimore, Maryland, 21218, United States

RECRUITING

NYU Langone Orthopedic Center

New York, New York, 10003, United States

RECRUITING

OSU Wexner Medical Center

Columbus, Ohio, 43212, United States

RECRUITING

University of Pennsylvania- Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The San Antonio Orthopaedic Group (TSAOG Orthopaedics)

San Antonio, Texas, 78258, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jacob Koffler, PhD, MBA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will occur to the subject and the blinded assessor. The blinded assessor will remain blinded from the device that was implanted. For subjects, blinding will be accomplished by informing subjects during the consent process that they may or may not also receive a secondary procedure in which they could have an incision in their leg that is not dependent on the device in which they are randomized to receive. Blinding will be assessed by the use of blinding assessment to both the assessor at the patient at the 12 month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 31, 2024
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (6)