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 range22 Years
SexALL
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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…