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PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
Sponsor: Microvention-Terumo, Inc.
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).
Official title: PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
475
Start Date
2026-12-31
Completion Date
2031-05-31
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
PHIL™ (Precipitating Hydrophobic Injectable Liquid)
Embolization of MMA with PHIL.
Surgical evacuation
Surgical evacuation of cSDH.