[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565970":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":36,"responsibleParty":53,"collaborators":57,"id":61,"slug":10,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IRRAflow device",null,"All patients enrolled into the study will undergo treatment with the IRRAflow device",[13],"Device: IRRAflow® CNS (Active Fluid Exchange) System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","IRRAflow® CNS (Active Fluid Exchange) System","The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.",[9],[21,24],{"name":22,"affiliation":5,"role":23},"Christopher Kellner","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":23},"Nicholas Brandmeir","West Virginia University",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Sukaina Davdani","CONTACT","(212) 241-2524","Sukaina.Davdani@mountsinai.org",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},"Sydney Edwards","Sydney.Edwards@mountsinai.org",[37],{"facility":5,"status":38,"city":39,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","New York","10029","United States",{"type":43,"coordinates":44},"Point",[45,46],-74.00597,40.71427,{"lat":46,"lon":45},[49,51,52],{"name":29,"role":30,"phone":50,"phoneExt":10,"email":32},"212-241-2524",{"name":34,"role":30,"phone":31,"phoneExt":10,"email":35},{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Christopher P Kellner","Associate Professor, Neurosurgery",[58],{"name":59,"class":60},"IRRAS","INDUSTRY","100565970",false,"NCT06649097","Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System","CRYSTAL","Inclusion criteria:\n\n* Age \\>=18 years of age\n* Intracranial hemorrhage documented on head CT or MRI scan.\n* Indication for active fluid exchange evaluated by treating physician.\n* Signed informed consent obtained by patient or Legal Authorized Representative\n* Scheduled enrollment and treatment within 72 hours of last known well (LKW)\n\nExclusion criteria:\n\n* GCS ≤ 5\n* Pregnancy\n* Fixed and dilated pupil\n* Life-threatening medical condition","ALL","18 Years",{"count":70,"type":71},250,"ESTIMATED","6 Months","OBSERVATIONAL","The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.",[76,77,78],"Intracranial Hemorrhage","Ventriculitis","Intracranial Abscess","2025-10-24",{"date":81,"type":82},"2025-10-28","ACTUAL",{"date":84,"type":82},"2025-09-25",{"date":86,"type":71},"2031-07",{"name":55,"class":6},1]