Trial Outcomes & Findings for 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. (NCT NCT04145544)

Last Updated: 2025-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

6 month.

Results posted on

2025-08-19

Participant Flow

The clinical trial was performed in 8 European medical centers (Poland, Czech Republic, Spain and Belgium) and in 1 Israeli medical center. Subjects were enrolled from January 2020 to January 2022.

A total of 92 subjects met the inclusion/exclusion criteria, were randomized and enrolled. Of those 92 subjects, 89 received surgical treatment. Of those 89 treated subjects, 85 completed the study.

Participant milestones

Participant milestones
Measure	Treatment Arm- ArtiFascia® Patch The treatment arm consists of subjects who were implanted with ArtiFascia® Dura Replacement device.	Control-Other Commercial Suturable Dural Substitute The control arm consists of other commercial suturable dural substitute, including: Neuro-patch, ReDura, Tachosil, Tutopatch and Duragen.
Overall Study STARTED	63	29
Overall Study Treated	62	27
Overall Study COMPLETED	58	27
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm-ArtiFascia® Graft n=63 Participants The treatment arm consists of patients implanted with ArtiFascia® graft following cranial surgery.	Control-Other Commercial Suturable Dural Substitute n=29 Participants The control arm consists of patients implanted with other commercial suturable dural substitute, including: Neuro-patch, ReDura, Tachosil, Tutopatch and Duragen.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=93 Participants	23 Participants n=4 Participants	71 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	5 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	21 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	8 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=93 Participants	4 Participants n=4 Participants	18 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=93 Participants	25 Participants n=4 Participants	74 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	62 Participants n=93 Participants	29 Participants n=4 Participants	91 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Belgium	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Czechia	19 participants n=93 Participants	9 participants n=4 Participants	28 participants n=27 Participants
Region of Enrollment Poland	28 participants n=93 Participants	12 participants n=4 Participants	40 participants n=27 Participants
Region of Enrollment Spain	13 participants n=93 Participants	6 participants n=4 Participants	19 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 month.

Outcome measures

Outcome measures
Measure	Control-Other Commercial Suturable Dural Substitute n=27 Participants The control arm consists of subjects implanted with other commercial suturable dural substitute, including: Neuro-patch, ReDura, Tachosil, Tutopatch and Duragen.	Treatment Arm-ArtiFascia® Graft n=58 Participants The treatment arm consists of subjects implanted with ArtiFascia® graft following cranial surgery.
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. Presence of cerebrospinal fluid fistula and Pseudomeningocele	0 Participants	0 Participants
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. No events of cerebrospinal fluid fistula and Pseudomeningocele	27 Participants	58 Participants

SECONDARY outcome

Timeframe: 6 month follow-up

Clean and/or fully healed vs. Infected. Evaluation of wound will be done in physical examination: clean and/or fully healed/ infected. If wound is infected additional assessment of mild/moderate/severe will be done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On the day of the surgical procedure

The following scoring system was used for the evaluation: 1\) Device ease of use, suturing and cutting were evaluated on a scale of 1=Easy to 5=Difficult. 2) Device strength and seal quality (during implantation) were scored on scale of 1=Low to 5=High.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month follow-up

The rate of each of the following: Extracerebral fluid accumulation, pseudomeningocele, adhesion formation, brain edema adjacent to device implant site, abnormal thickening at implantation site and new membrane (scar) formation.

Outcome measures

Outcome measures
Measure	Control-Other Commercial Suturable Dural Substitute n=58 Participants The control arm consists of subjects implanted with other commercial suturable dural substitute, including: Neuro-patch, ReDura, Tachosil, Tutopatch and Duragen.	Treatment Arm-ArtiFascia® Graft n=27 Participants The treatment arm consists of subjects implanted with ArtiFascia® graft following cranial surgery.
Radiological Imaging at 6 Months for Additional Findings at Implant Site Present measures	1 Participants	3 Participants
Radiological Imaging at 6 Months for Additional Findings at Implant Site No findings presence	57 Participants	24 Participants

Adverse Events

Treatment Arm-ArtiFascia® Graft

Serious events: 9 serious events

Other events: 26 other events

Deaths: 1 deaths

Control-Other Commercial Suturable Dural Substitute

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm-ArtiFascia® Graft n=63 participants at risk The treatment arm consists of patients implanted with ArtiFascia® graft following cranial surgery.	Control-Other Commercial Suturable Dural Substitute n=29 participants at risk The control arm consists of patients implanted with other commercial suturable dural substitute, including: Neuro-patch, ReDura, Tachosil, Tutopatch and Duragen.
Nervous system disorders Facial paresis	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Light chain disease	0.00% 0/63 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	3.4% 1/29 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Nervous system disorders Cerebral haemorrhage	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Infections and infestations Extradural abscess	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Infections and infestations Pneumonia	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Cardiac disorders Cardio-respiratory arrest	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Nervous system disorders Seizure	0.00% 0/63 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	3.4% 1/29 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Vascular disorders Vasospasm	0.00% 0/63 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	3.4% 1/29 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
Nervous system disorders Hemiplegia	1.6% 1/63 • Number of events 1 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	0.00% 0/29 • 2.5 years Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory findings in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

Other adverse events

Additional Information

Dr. Amir Bahar (COO & Clinical Director)

Nurami Medical Ltd

Phone: +972-747408888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60