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)
Dural Tear, Cerebrospinal Fluid Leak
About this trial
This is an interventional treatment trial for Dural Tear
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Subject is participating in another clinical trial using similar investigational devices/drugs
Sites / Locations
- Ziekenhuis Oost-Limburg
- St. Anne's University Hospital Brno
- Neurochirurgická klinika Přednosta FN Olomouc
- Rabin Medical Center (Beilinson, Hasharon)
- Medical University of Gdańsk
- Barlicki University Hospital
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario de Bellvitge
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Treatment arm
Control
Procedure will be performed under general anaesthesia. 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 the ArtiFascia® patch. Implantation of the ArtiFascia® will be according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use. Detailed instructions are in the instructions for use. Post operation the subject will stay at the hospital according to site standards and physician discretion.
Same procedure as for the treatment arm but using a commercial suturable dural substitute. 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.