NeuraGen 3D Pilot Study

Exclusion Criteria

• •Nerve to be repaired is a mixed motor nerve
• •Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
• •Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve.
• •Subject's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
• •Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
• •Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome).
• •Subject has an active infection of the area around the nerve defect.
• •Subject has unstable vital signs.
• •Subject has a disorder known to affect the peripheral nervous system (PNS) such as:
• •Subject has any systemic disease which may confound study results Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
• •Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
• •Subject has a history of injury to or a congenital abnormality of the target hand or limb which may impact nerve healing or confound study results.
• •Subject is pregnant (determined either by the subject's confirmation or a formal test).
• •Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.