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).
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
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
Parallel
PHIL™ (Precipitating Hydrophobic Injectable Liquid)
DeviceEmbolization of MMA with PHIL.
Surgical evacuation
Procedure/SurgerySurgical evacuation of cSDH.
Primary Safety Endpoint
Incidence of mRS 0-2.
Primary Effectiveness Endpoint
Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHIL™ MMAE arm.
Death or major disabling stroke.
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.
Resolution of cSDH without retreatment.
Neurological death
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
