PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma … (NCT07576998) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
475 participantsStarted 2026-12-31
Plain-language 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 arm).
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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
* Ser…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.