[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609441":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":23,"locations":32,"responsibleParty":64,"collaborators":7,"id":66,"slug":7,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":7,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":7,"briefSummary":80,"conditions":81,"keywords":7,"overallStatus":85,"whyStopped":7,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Kaneka Medical America LLC","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Neuro endovascular embolic coil","i-ED COIL, Kaneka Corporation",[14],"Embolization coil",[16,20],{"name":17,"affiliation":18,"role":19},"Fawaz Al-Mufti, MD","Westchester Medical Center","PRINCIPAL_INVESTIGATOR",{"name":21,"affiliation":22,"role":19},"Jan-Karl Burkhardt, MD","University of Pennsylvania",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":7,"email":28},"Yuki Arimoto","CONTACT","212-705-4340","yuki.arimoto@kaneka.com",{"name":30,"role":26,"phone":27,"phoneExt":7,"email":31},"Leah Lyons, PA","leah.lyons@kaneka.com",[33,49],{"facility":18,"status":7,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Valhalla","New York","10595","United States",{"type":39,"coordinates":40},"Point",[41,42],-73.77513,41.07482,{"lat":42,"lon":41},[45,48],{"name":17,"role":26,"phone":46,"phoneExt":7,"email":47},"914-493-5098","fawaz.al-mufti@wmchealth.org",{"name":17,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":50,"status":7,"city":51,"state":52,"zip":53,"country":37,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"University of Pennslyvania","Philadelphia","Pennsylvania","11104",{"type":39,"coordinates":55},[56,57],-75.16362,39.95238,{"lat":57,"lon":56},[60,63],{"name":21,"role":26,"phone":61,"phoneExt":7,"email":62},"917-597-9435","jan.burkhardt@pennmedicine.upenn.edu",{"name":21,"role":19,"phone":7,"phoneExt":7,"email":7},{"type":65,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100609441",false,"NCT07214623","Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy","i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study","iCURE cSDH","Inclusion Criteria:\n\n* Pre morbid mRS 0-3\n* Chronic subdural symptomatic, requiring intervention\n\nExclusion Criteria:\n\n* Acute subdural hematoma\n* Intercranial mass other than subdural hematoma\n* Females pregnant or breast feeding\n* Compromised survival or inability to complete trial","ALL","18 Years",{"count":76,"type":77},200,"ESTIMATED","6 Months","OBSERVATIONAL","All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.",[82,83,84],"Chronic Subdural Hematoma","cSDH","Chronic Subdural Hematomas","NOT_YET_RECRUITING","2025-10-02",{"date":88,"type":89},"2025-10-09","ACTUAL",{"date":91,"type":77},"2025-11-30",{"date":93,"type":77},"2027-05-31",{"name":5,"class":6},2]