Dural TearNEOARTNCT04145544
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.
A study testing Implantation of the ArtiFascia® and Implantation of other commercial suturable dural substitute in people with Dural Tear and Cerebrospinal Fluid Leak, run by Nurami Medical Ltd at 9 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dural Tear, Cerebrospinal Fluid Leak
- What is being tested?
- Implantation of the ArtiFascia® and Implantation of other commercial suturable dural substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 7 Jan 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Bellvitge
Barcelona, 09807
Czechia2 sites
St. Anne's University Hospital Brno
Brno, 656 91
Neurochirurgická klinika Přednosta FN Olomouc
Olomouc, 779 00
Poland2 sites
Medical University of Gdańsk
Gdansk, 80-214
Barlicki University Hospital
Lodz, 90-153
About this study
Official title: A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
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.
Read the detailed description
A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch compared with commercially available dural substitutes- NEOART Study.
The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF). The dura mater may be damaged as a result of trauma or planned surgery. When dural defects cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce CSF leakage.
There are devices that have been used as dural substitutes. Among the devices that are based on natural raw materials, collagen-based matrices are widely used. Although collagen was proven to be biocompatible, using collagen-based materials still possess several limitations such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most widely used raw-material for these synthetic products are polyesters - resorbable and biocompatible polymers. There are several dural substitutes based on synthetic polyesters that were successfully tested pre-clinically as well as in human studies.
Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a polymeric synthetic dural substitute that is absorbed by the body.
Before the study, all subjects underwent neurological assessment. Only subjects that were found to be suitable to participate in the study, and agree to participate, were randomly allocated into one of the following groups:
- Experimental group (ArtiFascia® device);
- Control group (Other commercially available suturable dural substitutes).
The Sponsor was blinded to treatment. The subjects underwent the planned surgery and at the end the investigator used ArtiFascia® patch or standard dural substitute to repair the damaged Dura. ArtiFascia® graft was placed in areas where the native dural layer was damaged or missing. ArtiFascia® was applied via a routine and well-known procedure, using a suturing technique. After implantation, the porous fibrous structure of ArtiFascia® provides a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, ultimately replacing damaged dural tissue. The patch is expected to resorb within a few months and to be replaced by the native tissue with complete dural closure.
During the surgery and until subject's release from the hospital the subject's health was closely monitored. Before the discharge subjects underwent neurological examination. Subjects had been followed up at 4-6 weeks and at 6 months post surgery.
At each follow up visit physical and neurological examinations were performed. Radiographic Evaluation (Magnetic Resonance Imaging) was performed at 6 months post operation.
A total of 92 subjects from 7 sites in Europe were enrolled and implanted with test or control device.
The primary endpoint was achieved when the final study subject has completed a 6-months follow-up.
- Conditions
- Dural Tear, Cerebrospinal Fluid Leak
- Being tested
- Implantation of the ArtiFascia®, Implantation of other commercial suturable dural substitute
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the ArtiFascia®Device
Following are the general instructions for use for the ArtiFascia®:
- Cut the ArtiFascia® to the required shape under aseptic conditions
- Apply ArtiFascia® to the damaged area
- Suture the ArtiFascia® in place
- Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision.
Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results.
Implantation of other commercial suturable dural substituteDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Procedure was performed under general anesthesia. The subjects underwent the planned surgery. At the end of the surgery, the investigator used the ArtiFascia® patch. Implantation of the ArtiFascia® was according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use.
Post operation the subject stayed at the hospital according to site standards and physician discretion. Receives: Device: Implantation of the ArtiFascia® |
| Control | Active comparator | Same procedure as for the treatment arm but using a commercial suturable dural substitute.
Implantation of the commercial suturable dural substitute was according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Receives: Device: Implantation of other commercial suturable dural substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.
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.
Measured: 6 month.
Secondary outcomes (3)
Wound Healing Assessment
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.
Measured: 6 month follow-up
Device Handling Characteristics as Reported by a User Experience Questionnaire
The following scoring system was used for the evaluation:
- 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.
Measured: On the day of the surgical procedure
Radiological Imaging at 6 Months for Additional Findings at Implant Site
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.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start7 Jan 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dural TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurami Medical Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145544
- Sponsor's protocol ID
- ARTIFASCIA® DURAL REPAIR PATCH
- Acronym
- NEOART
- Status last verified
- Aug 2025
- First submitted
- 21 Oct 2019
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
- ClinicalTrials.gov ID
- NCT04145544
- Acronym / sponsor ID
- NEOART / ARTIFASCIA® DURAL REPAIR PATCH
- Conditions
- Dural Tear, Cerebrospinal Fluid Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nurami Medical LtdUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch compared with commercially available dural substitutes- NEOART Study.
The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF). The dura mater may be damaged as a result of trauma or planned surgery. When dural defects cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce CSF leakage.
There are devices that have been used as dural substitutes. Among the devices that are based on natural raw materials, collagen-based matrices are widely used. Although collagen was proven to be biocompatible, using collagen-based materials still possess several limitations such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most widely used raw-material for these synthetic products are polyesters - resorbable and biocompatible polymers. There are several dural substitutes based on synthetic polyesters that were successfully tested pre-clinically as well as in human studies.
Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a polymeric synthetic dural substitute that is absorbed by the body.
Before the study, all subjects underwent neurological assessment. Only subjects that were found to be suitable to participate in the study, and agree to participate, were randomly allocated into one of the following groups:
- Experimental group (ArtiFascia® device);
- Control group (Other commercially available suturable dural substitutes).
The Sponsor was blinded to treatment. The subjects underwent the planned surgery and at the end the investigator used ArtiFascia® patch or standard dural substitute to repair the damaged Dura. ArtiFascia® graft was placed in areas where the native dural layer was damaged or missing. ArtiFascia® was applied via a routine and well-known procedure, using a suturing technique. After implantation, the porous fibrous structure of ArtiFascia® provides a scaffold, which enables infiltration of fibroblasts and cells from the intact tissue, ultimately replacing damaged dural tissue. The patch is expected to resorb within a few months and to be replaced by the native tissue with complete dural closure.
During the surgery and until subject's release from the hospital the subject's health was closely monitored. Before the discharge subjects underwent neurological examination. Subjects had been followed up at 4-6 weeks and at 6 months post surgery.
At each follow up visit physical and neurological examinations were performed. Radiographic Evaluation (Magnetic Resonance Imaging) was performed at 6 months post operation.
A total of 92 subjects from 7 sites in Europe were enrolled and implanted with test or control device.
The primary endpoint was achieved when the final study subject has completed a 6-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Implantation of the ArtiFascia®Procedure was performed under general anesthesia. The subjects underwent the planned surgery. At the end of the surgery, the investigator used the ArtiFascia® patch. Implantation of the ArtiFascia® was according to clinical discretion of the physician, and in compliance with ArtiFascia® instructions for use. Post operation the subject stayed at the hospital according to site standards and physician discretion. |
| Control | Active comparator | Device: Implantation of other commercial suturable dural substituteSame procedure as for the treatment arm but using a commercial suturable dural substitute. Implantation of the commercial suturable dural substitute was according to clinical discretion of the physician, and in compliance with each specific device instructions for use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the ArtiFascia®Following are the general instructions for use for the ArtiFascia®: * Cut the ArtiFascia® to the required shape under aseptic conditions * Apply ArtiFascia® to the damaged area * Suture the ArtiFascia® in place * Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision. Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results. | Device | Treatment arm |
| Implantation of other commercial suturable dural substituteImplantation 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 | Device | Control |
Primary outcome
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.
Time frame: 6 month.
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.
3 secondary outcomes
Wound Healing Assessment
Time frame: 6 month follow-up
Device Handling Characteristics as Reported by a User Experience Questionnaire
Time frame: On the day of the surgical procedure
Radiological Imaging at 6 Months for Additional Findings at Implant Site
Time frame: 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dural Tear
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CerebroSpinal Fluid (CSF) Leak, Dural Tear
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the ArtiFascia® and Implantation of other commercial suturable dural substitute in people with Dural Tear and Cerebrospinal Fluid Leak, run by Nurami Medical Ltd at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Czechia, Poland, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. (time frame: 6 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025; AzTrials last refreshed its copy on 4 Nov 2026.