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

NCT07576998 | Not Yet Recruiting FDA Device

• 1 other identifier: CL1108390
• Study Type: interventional
• Target: 475
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Chronic Subdural Hematomas

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Incidence of mRS 0-2.

  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.

  90 days post procedure

Secondary Outcomes (8)

• Death or major disabling stroke.

  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.

  180 days post procedure

• Resolution of cSDH without retreatment.

  90- and 180-days post procedure

• Neurological death

  90- and 180-days post procedure

• Change in EQ-5D-5L from baseline

  90- and 180-days post procedure

Study Arms (2)

Surgical management

ACTIVE COMPARATOR

Control arm

Procedure: Surgical evacuation

PHIL embolic

EXPERIMENTAL

Treatment arm

Device: PHIL™ (Precipitating Hydrophobic Injectable Liquid)

Interventions

PHIL™ (Precipitating Hydrophobic Injectable Liquid) DEVICE

Embolization of MMA with PHIL.

PHIL embolic

Surgical evacuation PROCEDURE

Surgical evacuation of cSDH.

Surgical management

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• David Fiorella

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Tran

CONTACT

949-678-1949; jennifer.tran@terumo.com

Amy Bowles

CONTACT

714-482-8074; amy.bowles@microvention.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sponsor is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2031
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share