[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612783":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":45,"armGroups":41,"interventions":46,"overallOfficials":41,"centralContacts":51,"locations":63,"responsibleParty":146,"collaborators":41,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":41,"enrollmentInfo":158,"targetDuration":41,"studyType":161,"phases":41,"briefSummary":162,"conditions":163,"keywords":41,"overallStatus":98,"whyStopped":41,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrence or progression of subdural hematoma","Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH.\n\n\\*\\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.","within 3 months",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Efficacy (1. Time)","Time period from symptoms to embolization","V1, preoperatively (baseline visit)",{"measure":19,"description":20,"timeFrame":21},"Efficacy (2. Time)","Time period from burr-hole drainage to embolization","V2, surgery (index procedure)",{"measure":23,"description":24,"timeFrame":25},"Efficacy (3. Time)","Time period from embolization to recurrence","6 months",{"measure":27,"description":28,"timeFrame":29},"Efficacy (4. Hematoma thickness)","Change in hematoma thickness","at V4: 3 months and V5: 6 months compared to baseline",{"measure":31,"description":32,"timeFrame":33},"Efficacy (5. Change in midlind shift)","Change in midline shift compared to baseline","at V4: 3 months and V5: 6 months",{"measure":35,"description":36,"timeFrame":37},"Efficacy (6. Cognitive assessment)","Mini-Mental State Examination (MMSE) from 0 (severe cognitive impairment) to 30 (no cognitive impairment)","V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months",{"measure":39,"description":40,"timeFrame":37},"Quality of life, EQ-5D-5L","assessed by EQ-5D scale from 0 (worst health) to 100 (best health)",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town).",[47],{"type":48,"name":49,"description":50,"armGroupLabels":41,"otherNames":41},"DEVICE","Histoacryl®","Histoacryl® is used by direct needle puncture, transcatheter approach, or transendoscopic approach in vascular embolization for the described purposes.",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Marta Soteras, Dr.","CONTACT","+34 935 8662","00","studies@aesculap.de",{"name":59,"role":54,"phone":60,"phoneExt":61,"email":62},"Yumiko Okaniva, Dr.","+81 3814","2525","gen.jp@bbraun.jp",[64,82,96,111,120,132],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Kokura Memorial Hospital","NOT_YET_RECRUITING","Fukuoka","Kitakyushu-city","〒802-8555","Japan","JP",{"type":73,"coordinates":74},"Point",[75,76],130.41667,33.6,{"lat":76,"lon":75},[79],{"name":80,"role":54,"phone":81,"phoneExt":41,"email":41},"Taketo Hatano, Dr.","093-511-2000",{"facility":83,"status":66,"city":84,"state":85,"zip":86,"country":70,"countryCode":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Ohara HealthCare Foundation Kurashiki Central Hospital","Okayama","Kurashiki","〒710-8602",{"type":73,"coordinates":88},[89,90],133.93333,34.65,{"lat":90,"lon":89},[93],{"name":94,"role":54,"phone":95,"phoneExt":41,"email":41},"Masanori Kinosada, Dr.","086-422-0210",{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":70,"countryCode":71,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Shimizu Hospital","RECRUITING","Kyoto","Nishikyo-ku","〒615-8237",{"type":73,"coordinates":103},[104,105],135.75385,35.02107,{"lat":105,"lon":104},[108],{"name":109,"role":54,"phone":110,"phoneExt":41,"email":41},"Nobuyuki Sakai, Dr.","075-381-5161",{"facility":112,"status":98,"city":113,"state":114,"zip":115,"country":70,"countryCode":71,"cosmosGeoPoint":41,"geoPoint":41,"contacts":116},"National Hospital Organization Osaka National Hospital","Osaka-Fu","Osaka-shi","〒540-0006",[117],{"name":118,"role":54,"phone":119,"phoneExt":41,"email":41},"Toshiyuki Fujinaka, Dr.","06-6942-1331",{"facility":121,"status":98,"city":99,"state":122,"zip":123,"country":70,"countryCode":71,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Kyoto University Hospital","Sakyo-ku","〒606-8507",{"type":73,"coordinates":125},[104,105],{"lat":105,"lon":104},[128],{"name":129,"role":54,"phone":130,"phoneExt":131,"email":41},"Chiaki Sakai, Dr.","0570-030","311",{"facility":133,"status":66,"city":134,"state":135,"zip":136,"country":70,"countryCode":71,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"National Cerebral and Cardiovascular Center","Osaka","Suita","〒564-8565",{"type":73,"coordinates":138},[139,140],135.50107,34.69379,{"lat":140,"lon":139},[143],{"name":144,"role":54,"phone":145,"phoneExt":41,"email":41},"Masakazu Okawa, Dr.","0570-012-545",{"type":147,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100612783","study-on-histoacryl-used-for-embolization-of-middle-meningeal-artery-mma-in-chronic-subdural-hematoma-csdh-harmony-100612783",false,"NCT07258069","Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)","Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)","HARMONY","Inclusion Criteria:\n\n* 18 years old or older\n* Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH)\n* Completed documented informed consent\n* Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)\n\nExclusion Criteria:\n\n* Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment\n* Need craniotomy\n* Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)\n* Coagulation dysfunction with INR\\>1.8 and\u002For platelet count \\\u003C80x109 \u002FL\n* Allergic reactions to essential medicines to do angiography\n* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study\n* Participation in another clinical trial","ALL","18 Years",{"count":159,"type":160},178,"ESTIMATED","OBSERVATIONAL","The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.",[164,165],"Subdural Hematoma","Subdural Hematoma, Chronic","2026-10-08",{"date":168,"type":169},"2026-10-09","ACTUAL",{"date":171,"type":169},"2026-04-10",{"date":173,"type":160},"2027-08",{"name":5,"class":6},6]