Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06529835

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

Led by Auxilium Biotechnologies · Updated on 2025-11-10

80

Participants Needed

6

Research Sites

175 weeks

Total Duration

On this page

Sponsors

A

Auxilium Biotechnologies

Lead Sponsor

M

MCRA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 is 3 mm or less
  • Nerve injury located in the arm from shoulder to wrist including the hand, or leg from hip to ankle including the foot
  • For motor nerve injuries: distance from injury to nearest innervated muscle is 100 mm or less
  • For sensory and mixed nerve injuries: distance from injury to nearest sensory nerve target is 250 mm or less
  • Repair must be done within 3 months of injury
  • No contraindications to surgical repair such as risk of infection or dog bite
Not Eligible

You will not qualify if you...

  • Previous nerve repair attempt on the treated nerve
  • Diseases that reduce nerve regeneration such as diabetes, non-traumatic peripheral neuropathy, chemotherapy treatment, or other peripheral neuropathies
  • Allergy to bovine products like bovine collagen nerve cuff
  • Pregnancy or planning to become pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 6 locations

1

UCSF Orthopedic Institute

San Francisco, California, United States, 94158

Actively Recruiting

2

Medstar Union Memorial Hospital- The Curtis National Hand Center

Baltimore, Maryland, United States, 21218

Actively Recruiting

3

NYU Langone Orthopedic Center

New York, New York, United States, 10003

Actively Recruiting

4

OSU Wexner Medical Center

Columbus, Ohio, United States, 43212

Actively Recruiting

5

University of Pennsylvania- Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

6

The San Antonio Orthopaedic Group (TSAOG Orthopaedics)

San Antonio, Texas, United States, 78258

Actively Recruiting

Loading map...

Research Team

J

Jacob Koffler, PhD, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here