An interventional study of NeuroSpan Bridge and NeuroGen Nerve Guide in Peripheral Nerve Injuries, sponsored by Auxilium Biotechnologies. Recruiting at 8 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Auxilium Biotechnologies · Not applicable, Interventional, and Treatment
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
87 studies on the registry are indexed under Peripheral Nerve Injuries; 20 are open to participants now.
This study's planned enrollment of 80 is above the median of 44 across 58 interventional studies indexed under Peripheral Nerve Injuries.
Browse Peripheral Nerve Injuries studies →This is the only study on the registry with Auxilium Biotechnologies as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
Device: NeuroSpan Bridge · Device: NeuroGen Nerve Guide
The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
Device: NeuroSpan Bridge · Device: Nerve Autograft
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 stump.
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 Factor.
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.
This endpoint will examine the change in 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.
This endpoint will examine 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
Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.
This endpoint will examine 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.
This endpoint will examine 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.
This endpoint will examine 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.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months. The Disabilities of the Arm Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
Time frame: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months. The Disabilities of the Arm Shoulder and Hand (DASH) Work Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on the patients ability to work. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
Time frame: 12 months
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.
This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (Dash) Sports/Performing Arts Module at 12 months. The Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on their ability to play a musical instrument, participate in sport or both. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.
Time frame: 12 months
Decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.
This clinical measure will examine the decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.
Time frame: 12 months
Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.
This clinical measure will examine the comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.
Time frame: 12 months
Changes in Numerical Rating Scale (NRS) pain scores from baseline.
This clinical measure will examine changes in Numerical Rating Scale (NRS) pain scores from baseline. Numerical Rating Scale (NRS) is a pain scale that measures a patient's pain intensity or other features. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the 10 represents 'the worst pain ever possible'.
Time frame: 12 months
Hospital/Outpatient center readmission rates within 30 days of surgery.
This clinical measure will examine the Hospital/Outpatient center readmission rates within 30 days of surgery
Time frame: 30 days
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