A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
Phase: NA
Conditions: Dural Tear, Cerebrospinal Fluid Leak
Sponsor: Nurami Medical Ltd

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 1 of 6 
 
 
 
 
 
CLINICAL INVESTIGATION PLAN  
A PROSPECTIVE, RANDOMIZED, CONTROLLED MULTI-CENTER STUDY OF 
ARTIFASCIA® DURAL REPAIR PATCH COMPARED WITH COMMERCIALLY 
AVAILABLE DURAL SUBSTITUTES 
NEOART STUDY 
Protocol Number: CLN-01-1011 
 
Revision 05 
Date: February 03, 2021 
NCT04145544 
 
 
 
 
 
 
 
 
 
 
 
 

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 2 of 6 
 
Title 
A Prospective, randomized, controlled multi-center study of 
ArtiFascia® Dural repair patch compared with commercially 
available dural substitutes- NEOART Study.  
Device 
ArtiFascia® 
Intended Use 
ArtiFascia® is indicated as a dural substitute for the repair of 
dura matter. 
Study Design 
Prospective, randomized, multi-center, two-arm, single blind, 
parallel group clinical study. 
Study Objective 
To evaluate the safety and effectiveness of ArtiFascia® in 
comparison with commercially available dural substitutes in 
subjects requiring Dural repair following neurosurgery. 
Study Population 
Men and women scheduled for an elective cranial surgery 
that requires Dural repair, that meet the inclusion/exclusion 
criteria and can provide written Informed Consent. 
Enrollment  
A total of 90 subjects (81 + 9 to account for 10% loss to 
follow-up rate) will be enrolled and implanted with test or 
control device. To account for an assumed 10% loss to follow-
up rate, additional 9 subjects will be enrolled (60 in the 
ArtiFascia® group and 30 in the control group). 
Study Groups  
Subject will randomly be allocated into one of the following 
two groups in a 2:1 allocation ratio of ArtiFascia and control 
groups: 
• Experimental group: ArtiFascia® device 
• Control group: Other commercially available suturable 
dural substitutes (e.g. Duraform, Duragen, Durepair) 
Randomization 
Study population will be randomized using 2:1 ratio of 
experimental group (ArtiFascia device recipients) to control 
group (commercially available dural replacement recipients) 
respectively and preoperatively blinded.   
Duration of Study 
Completion of active enrolment is anticipated to last 
approximately 2 years. The primary endpoint will be achieved 
when the final study subject has completed a 6-months 
follow-up. The entire duration of the study is anticipated to 
require a total of 2.5 years. 

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 3 of 6 
 
Study Enrollment Start Date: 
November 2019 
 
Estimated Study Enrollment End Date: November 2021
 
 
Estimated Study Follow Up Completion: May 2022 
 
 
Investigational 
sites 
Up to 10 centers in Europe and Israel are planned to 
participate in this study.   
Duration of Subject  
Participation 
Each subject will be followed from pre-treatment to 6 
months. After discharge, subjects will come for a clinic visit at 
4-6 weeks and at 6 months post implantation. 
Primary Endpoint 
Absence of CSF fistula (drainage from wound or sinus) and 
pseudo-meningocele within 6 months post-operative as 
evaluated by MRI imaging.  
Secondary  
Endpoints  
1. Wound healing assessment 
2. Device Handling Characteristics (i.e., Ease of Use, 
strength Suturability, Seal Quality) 
3. Magnetic Resonance Imaging at the 6-month follow-up, 
to determine the presence or absence of the following 
measures:  
• Adhesion formation 
• New tissue formation 
• Brain edema adjacent to device implant site 
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 suturable dural substitute (ArtiFascia device or other 
commercially available dural substitutes) 
3. Subject has undergone 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 

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 4 of 6 
 
are performed 
6. Subject is able and willing to adhere to the required 
follow-up visits and testing  
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°C, 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 

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 5 of 6 
 
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 
Visits and 
Procedures 
Baseline: The baseline visit will include an assessment of 
subject qualifications for inclusion in the study according to 
the inclusion/exclusion criteria.  Informed consent must be 
signed. Medical data will be taken including subject's medical 
complaints, medical history, neurological assessment, and 
medications use. Blood tests will include CBC and chemistry 
(according to site standards).   
Randomization and Procedure: Vital signs (blood pressure, 
temperature, pulse rate), as well as height and weight will be 
measured prior procedure.   
The subject will be randomized during the index procedure 
after the physician confirmation that the subject fulfills all 
inclusion criteria. If found eligible, subject will be enrolled and 
randomized to one of the 2 groups: experimental group 
(ArtiFascia device recipients) or control group (commercially 
available suturable dural substitutes recipients). In addition, 
recruitment of subjects planned to undergo surgery in 
posterior fossa area will be limited to 15% of the total study 
sample size to ensure comparability to common rates of this 
procedure reported in the literature. 
Procedure will be performed under general anesthesia. 
ArtiFascia® or the control device will be implanted and 
sutured according to device IFU. Immediately post procedure 
essential data will be recorded including procedural details, 
surgeon’s opinion on device ease of use and suture-ability, 
and other procedure related complications and medications 
prescribed. 
Post operation the subject will stay at the hospital according 

 
Document Title: 
ArtiFascia® Clinical Investigation Plan-Pivotal Study 
 
Document I.D.: CLN-01-1011 
Date: 3.2.21 
Rev.: 05 
Page 6 of 6 
 
to site standards and physician discretion.  
Follow-up: After discharge, all subjects will have regular 
follow-up visits at 4-6 weeks and at 6 months post procedure.  
At discharge and at 4-6 weeks and 6-month visits, the 
following examinations may be performed: 
Physical examination of the surgical site to test CSF leakage 
Vital signs (blood pressure, temperature, pulse rate)– only at 
discharge and at 4-6 weeks 
Standard assessment of general neurological health  
Physical examination of the surgical site to test wound 
healing  
Adverse events will be assessed on a continuous basis from 
the baseline through the study completion at 6 months, and 
all events whether related or not related will be reported. 
Magnetic Resonance Imaging will be performed 6 months 
post operation in all subjects. 
During the follow-up period MRI may be performed if 
deemed necessary. In case MRI is performed, the presence of 
pseudo-meningocele or other internal CSF leakage in the 
implant area, will be evaluated. If MRI is performed more than 
3 months post operation and does not indicate presence of 
a leak, this data will be used to determine the leak rate and 
the subject will not be required to undergo an additional MRI 
at 6 months.