RECRUITING

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

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Conditions

Peripheral Nerve Injuries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-03-21
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06529835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
  2. 2. Nerve diameter at injury site ≤3mm.
  3. 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. 4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
  5. 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
  6. 6. Repair must take place within 3 months from injury
  7. 7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)
  1. 1. Previous history of nerve repair attempt at the treated nerve.
  2. 2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
  3. 3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
  4. 4. Pregnancy or planning to become pregnant

Contacts and Locations

Study Contact

Jacob Koffler, PhD, MBA
CONTACT
858-699-9443
j.koffler@auxiliumbio.com

Study Locations (Sites)

UCSF Orthopedic Institute
San Francisco, California, 94158
United States
NYU Langone Orthopedic Center
New York, New York, 10003
United States
OSU Wexner Medical Center
Columbus, Ohio, 43212
United States
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, Texas, 78258
United States

Collaborators and Investigators

Sponsor: Auxilium Biotechnologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-21
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-03-21
Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Nerve Injuries