[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609441":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":23,"locations":32,"responsibleParty":65,"collaborators":7,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":7,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":7,"briefSummary":82,"conditions":83,"keywords":7,"overallStatus":87,"whyStopped":7,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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",[33,50],{"facility":18,"status":7,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Valhalla","New York","10595","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-73.77513,41.07482,{"lat":43,"lon":42},[46,49],{"name":17,"role":26,"phone":47,"phoneExt":7,"email":48},"914-493-5098","fawaz.al-mufti@wmchealth.org",{"name":17,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":51,"status":7,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"University of Pennslyvania","Philadelphia","Pennsylvania","11104",{"type":40,"coordinates":56},[57,58],-75.16362,39.95238,{"lat":58,"lon":57},[61,64],{"name":21,"role":26,"phone":62,"phoneExt":7,"email":63},"917-597-9435","jan.burkhardt@pennmedicine.upenn.edu",{"name":21,"role":19,"phone":7,"phoneExt":7,"email":7},{"type":66,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100609441","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-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":78,"type":79},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.",[84,85,86],"Chronic Subdural Hematoma","cSDH","Chronic Subdural Hematomas","NOT_YET_RECRUITING","2025-10-02",{"date":90,"type":91},"2025-10-09","ACTUAL",{"date":93,"type":79},"2025-11-30",{"date":95,"type":79},"2027-05-31",{"name":5,"class":6},2]