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.

NCT04145544 | Completed Results DMC

• 1 other identifier: ARTIFASCIA® DURAL REPAIR PATCH
• Study Type: interventional
• Target: 92
• Locations: 5 countries
• Sites: 9

Brief Summary

The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery. Subjects with planned cranial neurosurgery participated in this study. During the surgery the 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. The damaged dura can be fixed with dural patch like ArtiFascia®. ArtiFascia® is a bioabsorbable medical synthetic dural replacement that aids in the regeneration of a new dura. Furthermore, it incorporates a sealing layer capable of minimizing CSF leakage and infection.

Conditions

Dural Tear; Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (1)

• Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.

  The primary end point will be assessed by evaluating the absence of cerebrospinal fluid fistula (drainage from wound or sinus) and pseudo-meningocele post-operative as evaluated by MRI imaging and physical examination of the surgical site.

  6 month.

Secondary Outcomes (3)

• Wound Healing Assessment

  6 month follow-up

• Device Handling Characteristics as Reported by a User Experience Questionnaire

  On the day of the surgical procedure

• Radiological Imaging at 6 Months for Additional Findings at Implant Site

  6 month follow-up

Study Arms (2)

Treatment arm

EXPERIMENTAL

Procedure was performed under general anesthesia. The subjects underwent the planned surgery. At the end of the surgery, the investigator used the ArtiFascia® patch. Implantation of the ArtiFascia® was according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use. Post operation the subject stayed at the hospital according to site standards and physician discretion.

Device: Implantation of the ArtiFascia®

Control

ACTIVE COMPARATOR

Same procedure as for the treatment arm but using a commercial suturable dural substitute. Implantation of the commercial suturable dural substitute was according to clinical discretion of the physician, and in compliance with each specific device instructions for use.

Device: Implantation of other commercial suturable dural substitute

Interventions

Implantation of the ArtiFascia® DEVICE

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.

Treatment arm

Implantation of other commercial suturable dural substitute DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject between the ages of 18-75
• Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suture-able dural substitute (ArtiFascia device or other commercially available dural substitutes)
• Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment
• Surgical wound is expected to be Class I/clean
• Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
• Subject is able and willing to adhere to the required follow-up visits and testing

You may not qualify if:

• Pregnant women or interest in becoming pregnant during the duration of the study
• Subject has known hydrocephalus
• Subject is unable to undergo MRI after the surgery
• Subject's life expectancy is less than 12 months
• Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever \> 38.3℃, positive blood culture and/or a positive chest x-ray for acute infectious process
• Subject will require use of dural adhesive or sealant
• Subject is intended to undergo craniectomy wherein bone flap will not be returned
• Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment)
• Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C\>6.5%), sepsis, systemic collagen disease.
• Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.
• Subject is an acute cranial trauma surgical case
• Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery
• Subject had a previous neurosurgery in the same anatomical site
• Subject with other undesirable symptoms defined by the principal investigator
• Patient has clinically significant coagulopathy as determined by the surgeon

Sponsors & Collaborators

• Nurami Medical Ltd: lead

Study Sites (9)

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

Location

St. Anne's University Hospital Brno

Brno, 656 91, Czechia

Location

Neurochirurgická klinika Přednosta FN Olomouc

Olomouc, 779 00, Czechia

Location

Rabin Medical Center (Beilinson, Hasharon)

Petah Tikva, 49100, Israel

Location

Medical University of Gdańsk

Gdansk, 80-214, Poland

Location

Barlicki University Hospital

Lodz, 90-153, Poland

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 09807, Spain

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Limitations and Caveats

No limitations.

Results Point of Contact

• Title: Dr. Amir Bahar (COO & Clinical Director)
• Organization: Nurami Medical Ltd

Amir@nurami-medical.com

+972-747408888

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 30, 2019
• Study Start: January 7, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

CZ (2); BE (1); ES (3); IL (1); PL (2)