[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565970":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":74,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"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,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","New York","10029","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.00597,40.71427,{"lat":47,"lon":46},[50,52,53],{"name":29,"role":30,"phone":51,"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":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Christopher P Kellner","Associate Professor, Neurosurgery",[59],{"name":60,"class":61},"IRRAS","INDUSTRY","100565970","clearance-of-intracranial-blood-products-by-continuous-irrigation-with-the-irraflow-system-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":72,"type":73},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.",[78,79,80],"Intracranial Hemorrhage","Ventriculitis","Intracranial Abscess","2025-10-24",{"date":83,"type":84},"2025-10-28","ACTUAL",{"date":86,"type":84},"2025-09-25",{"date":88,"type":73},"2031-07",{"name":56,"class":6},1]