Not currently recruiting at UCSF

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

Igor Immerman

Description

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

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)

Peripheral Nerve Injuries, NeuroSpan Bridge, NeuroGen Nerve Guide, Nerve Autograft

Open to people ages 18-80

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)

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

UCSF Orthopedic Institute not yet accepting patients
San Francisco California 94158 United States
The San Antonio Orthopaedic Group (TSAOG Orthopaedics) not yet accepting patients
San Antonio Texas 78258 United States
OSU Wexner Medical Center accepting new patients
Columbus Ohio 43212 United States
NYU Langone Orthopedic Center accepting new patients
New York New York 10003 United States

Igor Immerman, M.D.
Dr. Igor Immerman is an orthopaedic surgeon with specialty training in hand and upper extremity surgery. Treating all conditions of the upper extremity, from the simple to the complex, Dr. Immerman’s philosophy of care is that each patient should be treated as a unique person and not by a cookie-cutter, protocol-only approach.

Status: accepting new patients at some sites,
but this study is not currently recruiting here
Start Date: March 21, 2025
Completion Date: August 2028 (estimated)
Sponsor: Auxilium Biotechnologies
ID: NCT06529835
Study Type: Interventional
Participants: Expecting 80 study participants
Last Updated: May 9, 2025