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. — NEOART  

Cerebrospinal Fluid Leak Clinical Trial

Official title: A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• Dural Tear

• NCT number: NCT04145544
• Study type: Interventional
• Source: Nurami Medical Ltd
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Completion date: November 1, 2022