Chronic Subdural HematomasPHILFIRSTNCT07576998
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
A study testing PHIL™ (Precipitating Hydrophobic Injectable Liquid) and Surgical evacuation in people with Chronic Subdural Hematomas, run by Microvention-Terumo, Inc..
Trial summary
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Subdural Hematomas
- What is being tested?
- PHIL™ (Precipitating Hydrophobic Injectable Liquid) and Surgical evacuation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 May 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 years or older
- Diagnosis of chronic subdural hematoma
- Subject, or their legally authorized representative provides a signed and dated Informed Consent Form
- Pre-morbid mRS 0-1
- cSDH measures ≥ 10 mm in greatest thickness
- cSDH exerts mass effect upon the subjacent brain
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- Imaging characteristics indicative of chronicity
- Negative urine pregnancy test for female subjects of child-bearing potential
- Subject is able and willing to comply with all study protocol requirements, including return to the investigational site for all follow-up visits
- Subject presents with one or more of the following neurological symptoms: headache/head pressure, cognitive decline, speech difficulty or aphasia, gait impairment or imbalance, focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop), and/or seizure
Who cannot join
- Prior ipsilateral craniotomy or burr hole evacuation of cSDH
- Prior embolization of either MMA
- Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization
- Emergent subdural hematoma evacuation needed
- cSDH with a focal location
- cSDH developed due to underlying condition
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- Life expectancy of <1 year
- Presents with an intracranial mass other than subdural hematoma
- Presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- Serum creatinine level > 3.0 mg/dL at time of enrollment and not on dialysis
- Life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
- Currently enrolled in another investigational study protocol that could potentially confound the interpretation of the study endpoints/outcomes
- Known dangerous anatomic variations leading to increased procedural risk or unsafe access for MMAE
- Contraindicated for the use of PHIL™ liquid embolic system
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: PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
- Conditions
- Chronic Subdural Hematomas
- Being tested
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHIL™ (Precipitating Hydrophobic Injectable Liquid)Device
Embolization of MMA with PHIL.
Surgical evacuationProcedure or surgery
Surgical evacuation of cSDH.
| Study group | Role | What they receive |
|---|---|---|
| Surgical management | Active comparator | Control arm Receives: Procedure: Surgical evacuation |
| PHIL embolic | Experimental | Treatment arm Receives: Device: PHIL™ (Precipitating Hydrophobic Injectable Liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Incidence of mRS 0-2.
Measured: 90 days post procedure
Primary Effectiveness Endpoint
Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHIL™ MMAE arm.
Measured: 90 days post procedure
Secondary outcomes (8)
Death or major disabling stroke.
Measured: 30-, 90-, and 180-days post-index procedure
The composite of: recurrent or residual chronic subdural hematoma on the target side measuring ≥ 10 mm; retreatment; or major disabling stroke, myocardial infarction, or death from neurologic causes.
Measured: 180 days post procedure
Resolution of cSDH without retreatment.
Measured: 90- and 180-days post procedure
Neurological death
Measured: 90- and 180-days post procedure
Change in EQ-5D-5L from baseline
Measured: 90- and 180-days post procedure
cSDH-related hospital re-admissions and re-admission days
Measured: 90- and 180-days post procedure
Index hospitalization length of stay
Measured: post procedure
Neurological Events of Interest: minor stroke, major stroke, cSDH expansion, acute cSDH, mRS deterioration of 2 points or greater
Measured: 90 days and 180 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576998
- Sponsor's protocol ID
- CL1108390
- Acronym
- PHILFIRST
- Status last verified
- May 2026
- First submitted
- 21 Jan 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)
- ClinicalTrials.gov ID
- NCT07576998
- Acronym / sponsor ID
- PHILFIRST / CL1108390
- Conditions
- Chronic Subdural Hematomas
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 8 May 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.
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical management | Active comparator | Procedure: Surgical evacuationControl arm |
| PHIL embolic | Experimental | Device: PHIL™ (Precipitating Hydrophobic Injectable Liquid)Treatment arm |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 22 years or older
- Diagnosis of chronic subdural hematoma
- Subject, or their legally authorized representative provides a signed and dated Informed Consent Form
- Pre-morbid mRS 0-1
- cSDH measures ≥ 10 mm in greatest thickness
Key exclusion criteria (14 listed)
- Prior ipsilateral craniotomy or burr hole evacuation of cSDH
- Prior embolization of either MMA
- Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization
- Emergent subdural hematoma evacuation needed
- cSDH with a focal location
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 |
|---|---|---|
| PHIL™ (Precipitating Hydrophobic Injectable Liquid)Embolization of MMA with PHIL. | Device | PHIL embolic |
| Surgical evacuationSurgical evacuation of cSDH. | Procedure or surgery | Surgical management |
Primary outcome
Primary Safety Endpoint
Time frame: 90 days post procedure
Incidence of mRS 0-2.
Primary Effectiveness Endpoint
Time frame: 90 days post procedure
Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHIL™ MMAE arm.
8 secondary outcomes
Death or major disabling stroke.
Time frame: 30-, 90-, and 180-days post-index procedure
The composite of: recurrent or residual chronic subdural hematoma on the target side measuring ≥ 10 mm; retreatment; or major disabling stroke, myocardial infarction, or death from neurologic causes.
Time frame: 180 days post procedure
Resolution of cSDH without retreatment.
Time frame: 90- and 180-days post procedure
Neurological death
Time frame: 90- and 180-days post procedure
Change in EQ-5D-5L from baseline
Time frame: 90- and 180-days post procedure
cSDH-related hospital re-admissions and re-admission days
Time frame: 90- and 180-days post procedure
Index hospitalization length of stay
Time frame: post procedure
Neurological Events of Interest: minor stroke, major stroke, cSDH expansion, acute cSDH, mRS deterioration of 2 points or greater
Time frame: 90 days and 180 days post procedure
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
David Fiorella principal investigator
Stony Brook University
Questions about this trial
What is this clinical trial studying?
A study testing PHIL™ (Precipitating Hydrophobic Injectable Liquid) and Surgical evacuation in people with Chronic Subdural Hematomas, run by Microvention-Terumo, Inc..
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 10 inclusion and 14 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 8 May 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 Jennifer Tran (949-678-1949, jennifer.tran@terumo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 90 days post procedure). 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 8 May 2026.