CerebroSpinal Fluid (CSF) LeakNEOFIXNCT07765862
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
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 (CSF) Leak and Dural Tear, run by Nurami Medical Ltd.
Trial summary
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CerebroSpinal Fluid (CSF) 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
- 228 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operative inclusion criteria:
- Male or female aged ≥18 and <80 years.
- Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
- Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
- Surgical wound is expected to be Class I/clean.
- Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.
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- Intra-operative Inclusion criteria:
- CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.
- The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.
Who cannot join
- Pre-operative exclusion criteria:
- Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
- Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
- Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
- Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
- Subject had a previous surgery in the same anatomical site.
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- Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.
- Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).
- Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.
- Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, or positive blood culture.
- Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).
- Subjected is diagnosed with sepsis, or systemic collagen disease.
- Subject at high risk of delayed or failed wound healing due to past treatments or conditions.
- Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels >1.3 mg/dL.
- Subject was diagnosed with liver disease evident by any of the following test results: ALT > 55 U/L, AST > 48 U/L, ALP > 129 U/L, GGT > 61 U/L, Total bilirubin > 1.3 mg/dL, Albumin < 3.5 g/Dl, INR > 1.2, or PT > 15 sec.
- Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c > 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.
- Subject had chemotherapy and/or radiotherapy in the past 8 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 8 weeks after surgery.
- Subject requires an external ventricular or lumbar CSF drain that must be left in place after surgery.
- Subject has congenital or acquired coagulopathy.
- The subject was classified as exhibiting drug abuse.
- Subject has any condition that, in the Principal Investigator's judgment, may compromise the subject's safety or preclude compliance with the study investigation plan and/or device instructions.
- Subject is participating in another clinical trial that tests any other drug or device.
- Subject is pregnant or breast-feeding at screening or intends to become pregnant during the study period.
- Subject has known history of sensitivity or allergy to any component of the ArtiFix®.
- Intra-operative Exclusion criteria:
- Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
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 PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Dural Tear
- Being tested
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries., Standard of Care (Investigator Choice)
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 sterile, synthetic, single use, adhesive, resorbable sealant graft intended to seal and repair dural defects following cranial or spinal surgeries.
Standard of Care (Investigator Choice)Device
Standard-of-care for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used)
| Study group | Role | What they receive |
|---|---|---|
| ArtiFix the investigational device | Experimental | Not described Receives: Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. |
| Standard of care treatment | Active comparator | Not described Receives: Device: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Measured: at 120 days after ArtiFix® or control implantation
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Measured: at 120 days after ArtiFix® implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CerebroSpinal Fluid (CSF) 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurami Medical Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Milbaum, MD, Study director, Nurami Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765862
- Sponsor's protocol ID
- PLN-0000265
- Acronym
- NEOFIX
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)
- ClinicalTrials.gov ID
- NCT07765862
- Acronym / sponsor ID
- NEOFIX / PLN-0000265
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Dural Tear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Nurami Medical LtdUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 14 Aug 2026 (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 the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ArtiFix the investigational device | Experimental | Device: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. |
| Standard of care treatment | Active comparator | Device: Standard of Care (Investigator Choice) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged ≥18 and <80 years.
- Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
- Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
- Surgical wound is expected to be Class I/clean.
- Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.
Key exclusion criteria (26 listed)
- Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
- Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
- Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
- Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
- Subject had a previous surgery in the same anatomical site.
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 sterile, synthetic, single use, adhesive, resorbable sealant graft intended to seal and repair dural defects following cranial or spinal surgeries. | Device | ArtiFix the investigational device |
| Standard of Care (Investigator Choice)Standard-of-care for dural repair in spine or cranial procedures (only FDA cleared graft devices and approved sealants will be used) | Device | Standard of care treatment |
Primary outcome
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Time frame: at 120 days after ArtiFix® or control implantation
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
Time frame: at 120 days after ArtiFix® implantation.
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 23 Oct 2026.
- 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, MD study director
Nurami Medical
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 (CSF) 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 9 inclusion and 26 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 23 Oct 2026. 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?
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation. (time frame: at 120 days after ArtiFix® or control implantation). The study lists 2 primary outcomes in all. 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 23 Oct 2026.