A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Auxilium Biotechnologies · with MCRA · NCT06529835
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 80
- US sites recruiting
- 8
- Study start
- March 21, 2025
- Record last updated
- June 26, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Being studied: NeuroSpan Bridge; NeuroGen Nerve Guide; Nerve Autograft
Conditions: Peripheral Nerve Injuries
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Recruiting US locations
UC San Diego Health
San Diego, CA 92103
Site contact: Dominic Baun · 858-534-8268 · jbaun@health.ucsd.edu
UCSF Orthopedic Institute
San Francisco, CA 94158
Site contact: Aamna Haq · 415-514-8707 · aamna.haq@ucsf.edu
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, MD 21218
Site contact: Ike Fleming · 410-554-2486 · Ike.C.Fleming@Medstar.net
NYU Langone Orthopedic Center
New York, NY 10003
Site contact: Ann Hu · 646-501-2180 · Ann.Hu@nyulangone.org
OSU Wexner Medical Center
Columbus, OH 43212
Site contact: Emily Rice · 614-293-5871 · Emily.Rice2@osumc.edu
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, PA 19104
Site contact: Ellen Stinger · 215-273-5064 · Ellen.Stinger@Pennmedicine.upenn.edu
UT Health Houston
Houston, TX 77030
Site contact: Tien Do · 281-857-2353 · Tien.Do@uth.tmc.edu
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, TX 78258
Site contact: Amanda Strickland · 509-951-1382 · astrickland@tsaog.com
Study contacts (from the official record)
- Jacob Koffler, PhD, MBA · 858-699-9443 · j.koffler@auxiliumbio.com