N/A
N=92
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.
Dural Tear · Cerebrospinal Fluid Leak
Bottom Line
View on ClinicalTrials.gov: NCT04145544 ↗Enrolled (actual)
92
Serious AEs
13.0%
Results posted
Aug 2025
Primary outcome: Primary: Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. — 0; 0; 27; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantation of the ArtiFascia® (Device); Implantation of other commercial suturable dural substitute (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nurami Medical Ltd
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. |
0; 0; 27; 58 | — |
| SECONDARY Wound Healing Assessment |
— | — |
| SECONDARY Device Handling Characteristics as Reported by a User Experience Questionnaire |
— | — |
| SECONDARY Radiological Imaging at 6 Months for Additional Findings at Implant Site |
1; 3; 57; 24 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04145544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.