An interventional study of PHIL™ (Precipitating Hydrophobic Injectable Liquid) and Surgical evacuation in Chronic Subdural Hematomas, sponsored by Microvention-Terumo, Inc.. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
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).
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 475 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control arm
Procedure: Surgical evacuation
Treatment arm
Device: PHIL™ (Precipitating Hydrophobic Injectable Liquid)
Embolization of MMA with PHIL.
Surgical evacuation of cSDH.
Primary Safety Endpoint
Incidence of mRS 0-2.
Time frame: 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.
Time frame: 90 days post procedure
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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