Auxilium Neurospan | Clinical Research Studies Listing

Recruiting

18 years - 80 years

All

Phase N/A

1 Location

Brief description of study

Purpose is to study the performance of NeuroSpan Bridge vs. current standard of care using NeuraGen Nerve Guide or nerve autograft. It is expected to take 10 months to enroll, with 12-month follow-up schedule for total duration of 22 months. The study is looking to enroll 80 subjects enrolled over 8 sites. This will be a Multicenter, Prospective, Randomized, Subject and Evaluator Blinded clinical trial to assess the efficacy of Auxilium's NeuroSpan Bridge.

Detailed description of study

If selected to take part in this research study, you will complete a screening visit to gather some information and determine if you are eligible to continue with the study. The size of your nerve injury will be determined during the beginning part of the surgery. Once the injury size is known you will be put into a study group by chance (like a coin
toss/like drawing straws).

If you have a shorter nerve injury, you will have a 50:50 chance of being placed in the NeuroSpan Bridge or Collagen Nerve Cuff groups. If you have a longer nerve injury, you will have a 50:50 chance of being placed into the NeuroSpan Bridge or Autograft groups. After you are randomized to a treatment group you will receive the treatment assigned by randomization. Your doctor may have to make an incision in your leg to gather tissue to help repair the injured nerve.
During the surgery, if the surgeon cannot complete the procedure for any reason, you will be treated per the standard of care protocol (SOC) and you will be removed from the study.

After this procedure you will return to the clinic at post-operative months 1, 3, 6, 9, and 12 for assessment of your motor and sensory function of the injured nerve, as well as to complete questionnaires.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: This will be a Multicenter, Prospective, Randomized, Subject and Evaluator Blinded clinical trial to assess the efficacy of Auxilium’s NeuroSpan Bridge.
Age: 18 years - 80 years
Gender: All

Inclusion Criteria

1. Patients aged 18 to 80, with upper or lower extremity nerve injury with a gap of 0.5cm-3.0 cm in the arm from the shoulder to the wrist, including the hand, and the leg from the hip to the ankle, including the foot.
2. Nerve diameter at injury site ≤3 mm.
3. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
4. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm 5. Repair must take place within 3 months from injury 6. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

5. Repair must take place within 3 months from injury 6. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

6. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

Exclusion Criteria

1. Previous history of nerve repair attempt at the treated nerve. 2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy. 3. Allergy to bovine products such as Bovine Collagen Nerve Cuff. 4. Pregnancy or planning to become pregnant

2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.

3. Allergy to bovine products such as Bovine Collagen Nerve Cuff. 4. Pregnancy or planning to become pregnant

4. Pregnancy or planning to become pregnant

Updated on 28 Apr 2026. Study ID: 25-0672

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