A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Condition: Dural Tear; Cerebrospinal Fluid Leak
MeSH terms: Cerebrospinal Fluid Leak
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of ArtiFascia® in
      comparison with commercially available dural substitutes in patients requiring Dural repair
      following neurosurgery.

      Patients with planned cranial neurosurgery can take part in this study. During the surgery
      the soft membrane that covers the brain (called dura) is likely to be cut and damaged. A
      damaged dura can cause a leakage of brain fluids (cerebrospinal fluid [CSF] leakage) and
      increase the risk of infections. Sponsor of this study has developed the ArtiFascia®.
      ArtiFascia® is a medical synthetic dural substitute that is absorbed by the body. ArtiFascia®
      supports the re-formation of a new dura. In addition it has a sealant layer that can reduce
      CSF leakage and infection.
    

Detailed description: 
      A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch
      compared with commercially available dural substitutes- NEOART Study.

      The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and
      spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF).
      The dura mater may be damaged as a result of trauma or planned surgery. When dural defects
      cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce
      CSF leakage.

      There are devices that have been used as dural substitutes. Among the devices that are based
      on natural raw materials, collagen-based matrices are widely used. Although collagen was
      proven to be biocompatible, using collagen-based materials still possess several limitations
      such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most
      widely used raw-material for these synthetic products are polyesters - resorbable and
      biocompatible polymers. There are several dural substitutes based on synthetic polyesters
      that were successfully tested pre-clinically as well as in human studies.

      Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a medical synthetic dural
      substitute that is absorbed by the body.

      Before the study, the patients will have their blood taken and they will undergo neurological
      assessment. If they are suitable to participate in the study, and agree to participate, they
      will be randomly allocated into one of the following groups:

        -  Experimental group (ArtiFascia® device);

        -  Control group (Other commercially available suturable dural substitutes).

      The patients will undergo a surgery that is identical to the one that was planned by the
      surgeon. At the end of the surgery, the investigator will use ArtiFascia® patch or standard
      dural substitute to repair the damaged Dura. ArtiFascia® graft will be placed in areas where
      the native dural layer was damaged or missing. ArtiFascia® will be applied via a routine and
      well-known procedure, using a suturing technique. After implantation, the porous fibrous
      structure of ArtiFascia® provides a scaffold, which enables infiltration of fibroblasts and
      cells from the intact tissue, ultimately replacing damaged dural tissue. The patch is
      expected to resorb within a few months and to be replaced by the native tissue with complete
      dural closure.

      During the surgery and until patient's release from the hospital the patient's health will be
      closely monitored. Before the discharge patients will have to undergo neurological
      examination. Patients will be obligated to attend the follow up visits after the surgery at
      the dates scheduled by the attending physician.

      At each of the visits physical and neurological examinations will be performed. Radiographic
      Evaluation (Magnetic Resonance Imaging) will be performed also 6 months post operation.

      A total of 90 patients will be enrolled and implanted with test or control device. Up to 10
      centers in Europe and Israel are planned to participate in this study.

      The primary endpoint will be achieved when the final study subject has completed a 6-months
      follow-up.
    

Intervention name(s): Implantation of the ArtiFascia®; Implantation of other commercial suturable dural substitute
Intervention type(s): Device; Device
Intervention description(s): Following are the general instructions for use for the ArtiFascia®:
Cut the ArtiFascia® to the required shape under aseptic conditions
Apply ArtiFascia® to the damaged area
Suture the ArtiFascia® in place
Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision.
Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results.; Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment