Recruiting NCT06529835

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

No phase Interventional Peripheral Nerve Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: NeuroSpan Bridge, NeuroGen Nerve Guide, Nerve Autograft.
Who it may be relevant to: Registry conditions: Peripheral Nerve Injuries. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Device NeuroSpan Bridge
The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve
Device NeuroGen Nerve Guide
The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth F
Device Nerve Autograft
A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap

Efficacy- Static two-point discrimination (s2PD) measured at 12 months. [Time frame: 12 months]
Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit. [Time frame: 12 months]

Secondary outcome measures (6)

Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months. [Time frame: 12 months]
Sensory function assessed by the British Medical Research Council grading system at 12 months. [Time frame: 12 months]
Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months. [Time frame: 12 months]
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months. [Time frame: 12 months]
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months. [Time frame: 12 months]
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months. [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 8 centers

NCT: NCT06529835 · AUX-NS-001