Not currently recruiting at University of California Health

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

a study on Peripheral Nerve Injuries

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Igor Immerman, M.D. (ucsf)
Headshot of Igor Immerman
Igor Immerman

Description

Summary

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

Official Title

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18-80

  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)

You CAN'T join if...

  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

Locations

  • 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

Lead Scientist at University of California Health

  • Igor Immerman, M.D. (ucsf)
    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.

Details

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