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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm. 2. Nerve diameter at injury site ≤3mm. 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. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm 6. Repair must take place within 3 months from injury 7. 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Blinding will occur to the subject and the blinded assessor. The blinded assessor will remain blinded from the device that was implanted. For subjects, blinding will be accomplished by informing subjects during the consent process that they may or may not also receive a secondary procedure in which they could have an incision in their leg that is not dependent on the device in which they are randomized to receive. Blinding will be assessed by the use of blinding assessment to both the assessor at the patient at the 12 month follow-up visit.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
NeuroGen Nerve Guide 		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
    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.
  • 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 Factor.
Active Comparator
Nerve Autograft 		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
    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.
  • 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

Recruiting Locations

Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore 4347778, Maryland 4361885 21218
Contact:
Ike Fleming
410-554-2486
Ike.C.Fleming@Medstar.net

More Details

Status
Recruiting
Sponsor
Auxilium Biotechnologies

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.