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Dural Tear
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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.

Sponsored by Nurami Medical Ltd

About this trial

Last updated 3 years ago

Study ID

ARTIFASCIA® DURAL REPAIR PATCH

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Subject between the ages of 18-75

2. 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)

3. Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment

4. Surgical wound is expected to be Class I/clean

5. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

6. Subject is able and willing to adhere to the required follow-up visits and testing

No

Exclusion Criteria

1. Pregnant women or interest in becoming pregnant during the duration of the study

2. Subject has known hydrocephalus

3. Subject is unable to undergo MRI after the surgery

4. Subject's life expectancy is less than 12 months

5. 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

6. Subject will require use of dural adhesive or sealant

7. Subject is intended to undergo craniectomy wherein bone flap will not be returned

8. 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)

9. 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.

10. 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.

11. Subject is an acute cranial trauma surgical case

12. Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery

13. Subject had a previous neurosurgery in the same anatomical site

14. Subject with other undesirable symptoms defined by the principal investigator

15. Patient has clinically significant coagulopathy as determined by the surgeon

16. Subject is participating in another clinical trial using similar investigational devices/drugs

Locations

Location

Status