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NOT YET RECRUITING
NCT07576998
NA

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

Sponsor: Microvention-Terumo, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

PHIL™ (Precipitating Hydrophobic Injectable Liquid)

Embolization of MMA with PHIL.

PROCEDURE

Surgical evacuation

Surgical evacuation of cSDH.