[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":26,"responsibleParty":47,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":26,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":26,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"Microvention-Terumo, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgical management","ACTIVE_COMPARATOR","Control arm",[13],"Procedure: Surgical evacuation",{"label":15,"type":16,"description":17,"interventionNames":18},"PHIL embolic","EXPERIMENTAL","Treatment arm",[19],"Device: PHIL™ (Precipitating Hydrophobic Injectable Liquid)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PHIL™ (Precipitating Hydrophobic Injectable Liquid)","Embolization of MMA with PHIL.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Surgical evacuation","Surgical evacuation of cSDH.",[9],[33],{"name":34,"affiliation":35,"role":36},"David Fiorella","Stony Brook University","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Jennifer Tran","CONTACT","949-678-1949","jennifer.tran@terumo.com",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Amy Bowles","714-482-8074","amy.bowles@microvention.com",{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100641048","phil-middle-meningeal-artery-embolization-for-first-line-treatment-of-chronic-subdural-hematoma-ide-trial-100641048",false,"NCT07576998","PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial","PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH) IDE Trial (PHILFIRST)","PHILFIRST","Inclusion Criteria:\n\n* Age 22 years or older\n* Diagnosis of chronic subdural hematoma\n* Subject, or their legally authorized representative provides a signed and dated Informed Consent Form\n* Pre-morbid mRS 0-1\n* cSDH measures ≥ 10 mm in greatest thickness\n* cSDH exerts mass effect upon the subjacent brain\n* Imaging characteristics indicative of chronicity\n* Negative urine pregnancy test for female subjects of child-bearing potential\n* Subject is able and willing to comply with all study protocol requirements, including return to the investigational site for all follow-up visits\n* Subject presents with one or more of the following neurological symptoms: headache\u002Fhead 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\u002For seizure\n\nExclusion Criteria:\n\n* Prior ipsilateral craniotomy or burr hole evacuation of cSDH\n* Prior embolization of either MMA\n* Requires (in the opinion of the treating surgeon) full or mini-craniotomy at time of randomization\n* Emergent subdural hematoma evacuation needed\n* cSDH with a focal location\n* cSDH developed due to underlying condition\n* Life expectancy of \\\u003C1 year\n* Presents with an intracranial mass other than subdural hematoma\n* Presents with a meningioma with mass effect and\u002For ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region\n* Serum creatinine level \\> 3.0 mg\u002FdL at time of enrollment and not on dialysis\n* Life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)\n* Currently enrolled in another investigational study protocol that could potentially confound the interpretation of the study endpoints\u002Foutcomes\n* Known dangerous anatomic variations leading to increased procedural risk or unsafe access for MMAE\n* Contraindicated for the use of PHIL™ liquid embolic system","ALL","22 Years",{"count":60,"type":61},475,"ESTIMATED","INTERVENTIONAL",[64],"NA","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).",[67],"Chronic Subdural Hematomas","NOT_YET_RECRUITING","2026-05-04",{"date":71,"type":72},"2026-05-08","ACTUAL",{"date":74,"type":61},"2026-12-31",{"date":76,"type":61},"2031-05-31",{"name":5,"class":6}]