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NCT Number: NCT07576998

PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial

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).

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Key information

Conditions

Chronic Subdural Hematomas Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

PHIL™ (Precipitating Hydrophobic Injectable Liquid)

Device

Embolization of MMA with PHIL.

Surgical evacuation

Procedure

Surgical evacuation of cSDH.

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 90 days post procedure

    Incidence of mRS 0-2.

  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.

Secondary outcomes

  1. Death or major disabling stroke.

    Time frame: 30-, 90-, and 180-days post-index procedure

  2. 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

  3. Resolution of cSDH without retreatment.

    Time frame: 90- and 180-days post procedure

  4. Neurological death

    Time frame: 90- and 180-days post procedure

  5. Change in EQ-5D-5L from baseline

    Time frame: 90- and 180-days post procedure

  6. cSDH-related hospital re-admissions and re-admission days

    Time frame: 90- and 180-days post procedure

  7. Index hospitalization length of stay

    Time frame: post procedure

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Bowles

CONTACT

[email protected]

714-482-8074

Jennifer Tran

CONTACT

[email protected]

949-678-1949

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)

Acronym: PHILFIRST

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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