Menu
Not yet recruiting NCT07576998

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

No phase Interventional Chronic Subdural Hematomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation.
Who it may be relevant to
Registry conditions: Chronic Subdural Hematomas. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Device PHIL™ (Precipitating Hydrophobic Injectable Liquid)
    Embolization of MMA with PHIL.
  • Procedure Surgical evacuation
    Surgical evacuation of cSDH.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: 90 days post procedure]
  • Primary Effectiveness Endpoint [Time frame: 90 days post procedure]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07576998 · CL1108390

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗