Cerebrospinal Fluid LeakNCT07092267
Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
A study testing ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. in people with Cerebrospinal Fluid Leak and Dural Tear, run by Nurami Medical Ltd.
Trial summary
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Cerebrospinal Fluid Leak, Dural Tear
- What is being tested?
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject between the ages of 22-65 (inclusive)
- Subject is scheduled for an elective cranial or spinal surgery with a single dural defect that could not be completely repaired by primary suture. The dural defect must not exceed 6cm2 (e.g. defects of sizes 2cm X 3cm, 1cm X 5cm, can be included). The defect can be completely repaired/closed by a dural sealant graft with an overlap of 6 mm with the surrounding intact dura (only 1 graft can be implanted in each subject in a single location).
- Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.
- Surgical wound is expected to be Class I/clean.
- Subject understands the study requirements and procedures, can provide written Informed Consent and is able and willing to adhere to the required follow-up visits and testing.
Who cannot join
- Subject has known hydrocephalus.
- Subject is unable to undergo MRI after the surgery.
- Subject's life expectancy is less than 12 months.
- Significant intraoperative hemorrhage that mandates blood transfusion.
- Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia etc.) or evidence of any surgical site infection, fever > 38.3°C, positive blood culture and/or a positive chest x-ray for acute inflammatory process.
- Subject has acquired or congenital compromised immune system and/or autoimmune disease, and/or is taking chronic immunosuppressant agents at baseline.
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- Subject will require use of other forms of dural repair (i.e. dural graft or sealant).
- Subject is intended to undergo craniectomy wherein bone flap will not be returned.
- Subject with a compromised wound healing process due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other concurrent conditions (e.g. 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, and 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 or had intracranial hemorrhage from any cause (hemorrhagic stroke, ruptured aneurysm etc.).
- Subject that has a concurrent disease or symptoms or conditions that would place the patient in excessive risk to the planned surgery - defined by PI.
- Subject had a previous neurosurgery in the same anatomical site.
- Subject was diagnosed with clinically significant coagulopathy as determined by the surgeon.
- Subject is participating in another clinical trial using investigational devices/drugs
- Subjects who previously participated in any investigational drug or device study within 30 days of screening
- Subject has known history of sensitivity or allergy to any component of the ArtiFix®.
- Female subjects who are breastfeeding, pregnant or interested in becoming pregnant during the duration of the study.
- Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multiple Center, Prospective, Single-arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.
- Conditions
- Cerebrospinal Fluid Leak, Dural Tear
- Being tested
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
- 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.
ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.Device
ArtiFix® is a synthetic surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. ArtiFix® adheres to the dura, so that sutures are not required to prevent cerebrospinal fluid (CSF) leakage.
| Study group | Role | What they receive |
|---|---|---|
| Subjects requiring Dural repair during elective neurosurgery procedures. | Experimental | Men and women scheduled for an elective cranial or spinal surgery that requires Dural repair during elective neurosurgery procedure. The investigated device is a surgical Dural sealant graft intended to close Dural defects. Receives: Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation.
Measured: up to 120 days after ArtiFix® implantation
Secondary outcomes (5)
Evaluation of CSF leakage rate via MRI at 120 days after ArtiFix® implantation Evaluation of CSF leakage rate via MRI at 330 days after ArtiFix® implantation
Measured: at 120 and 330 days after ArtiFix® implantation.
To evaluate the frequency and severity of device-related adverse events, up to 330 days post ArtiFix® implantation.
Measured: up to 330 days post ArtiFix® implantation.
Wound healing at implant site up to 30 days after implantation.
Measured: Up to 30 days after implantation.
Device Handling Characteristics, as reported by the surgeon [e.g. Ease of Use, Strength, Seal Quality, Reapplication (if occurred), adhesion to surgical tools]. Device Handling Characteristics reported by user experience questionnaire.
Measured: Following investigational device implantation on the day of the surgical procedure.
Magnetic Resonance Imaging at the 120 and 330 days follow-up, to determine the presence or absence of the following conditions: • Adhesion formation • Scarring • Brain edema adjacent to device implant site
Measured: At the 120 and 330 days follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurami Medical Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Joseph Milbaum, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092267
- Sponsor's protocol ID
- CLN-02-1026
- Status last verified
- Aug 2025
- First submitted
- 1 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Center, Prospective, Single-arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
- ClinicalTrials.gov ID
- NCT07092267
- Acronym / sponsor ID
- CLN-02-1026
- Conditions
- Cerebrospinal Fluid Leak, Dural Tear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nurami Medical LtdUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects requiring Dural repair during elective neurosurgery procedures. | Experimental | Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.Men and women scheduled for an elective cranial or spinal surgery that requires Dural repair during elective neurosurgery procedure. The investigated device is a surgical Dural sealant graft intended to close Dural defects. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject between the ages of 22-65 (inclusive)
- Subject is scheduled for an elective cranial or spinal surgery with a single dural defect that could not be completely repaired by primary suture. The dural defect must not exceed 6cm2 (e.g. defects of sizes 2cm X 3cm, 1cm X 5cm, can be included). The defect can be completely repaired/closed by a dural sealant graft with an overlap of 6 mm with the surrounding intact dura (only 1 graft can be implanted in each subject in a single location).
- Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.
- Surgical wound is expected to be Class I/clean.
- Subject understands the study requirements and procedures, can provide written Informed Consent and is able and willing to adhere to the required follow-up visits and testing.
Key exclusion criteria (20 listed)
- Subject has known hydrocephalus.
- Subject is unable to undergo MRI after the surgery.
- Subject's life expectancy is less than 12 months.
- Significant intraoperative hemorrhage that mandates blood transfusion.
- Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia etc.) or evidence of any surgical site infection, fever > 38.3°C, positive blood culture and/or a positive chest x-ray for acute inflammatory 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 |
|---|---|---|
| ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.ArtiFix® is a synthetic surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. ArtiFix® adheres to the dura, so that sutures are not required to prevent cerebrospinal fluid (CSF) leakage. | Device | Subjects requiring Dural repair during elective neurosurgery procedures. |
Primary outcome
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation.
Time frame: up to 120 days after ArtiFix® implantation
5 secondary outcomes
Evaluation of CSF leakage rate via MRI at 120 days after ArtiFix® implantation Evaluation of CSF leakage rate via MRI at 330 days after ArtiFix® implantation
Time frame: at 120 and 330 days after ArtiFix® implantation.
To evaluate the frequency and severity of device-related adverse events, up to 330 days post ArtiFix® implantation.
Time frame: up to 330 days post ArtiFix® implantation.
Wound healing at implant site up to 30 days after implantation.
Time frame: Up to 30 days after implantation.
Device Handling Characteristics, as reported by the surgeon [e.g. Ease of Use, Strength, Seal Quality, Reapplication (if occurred), adhesion to surgical tools]. Device Handling Characteristics reported by user experience questionnaire.
Time frame: Following investigational device implantation on the day of the surgical procedure.
Magnetic Resonance Imaging at the 120 and 330 days follow-up, to determine the presence or absence of the following conditions: • Adhesion formation • Scarring • Brain edema adjacent to device implant site
Time frame: At the 120 and 330 days follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Milbaum study director
Questions about this trial
What is this clinical trial studying?
A study testing ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. in people with Cerebrospinal Fluid Leak and Dural Tear, run by Nurami Medical Ltd.
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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir Bahar (+972-54-4487673, amir@nurami-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation. (time frame: up to 120 days after ArtiFix® implantation). 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 14 Aug 2025.