[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608723":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":58,"locations":68,"responsibleParty":83,"collaborators":85,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":37,"enrollmentInfo":102,"targetDuration":37,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":71,"whyStopped":37,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,15,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"RAINBOW-LBH substudy","EXPERIMENTAL","This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate the efficacy and safety of AI-assisted robotic-guided endoscopic hematoma evacuation for patients with large basal ganglia hemorrhage (LBH).",[13,14],"Procedure: AI-assisted robotic-guided endoscopic hematoma evacuation","Procedure: Conventional craniotomy",{"label":16,"type":10,"description":17,"interventionNames":18},"RAINBOW-MBH substudy","This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with moderate basal ganglia hemorrhage (MBH).",[19,20],"Procedure: AI-assisted robotic-guided puncture and hematoma evacuation","Other: Standard medical management",{"label":22,"type":10,"description":23,"interventionNames":24},"RAINBOW-IVH substudy","This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided endoscopic ventricular hematoma evacuation with external ventricular drainage for patients with intraventricular hemorrhage (IVH)",[25,26],"Procedure: AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage","Procedure: External ventricular drainage (EVD)",{"label":28,"type":10,"description":29,"interventionNames":30},"RAINBOW-BSH substudy","This substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with brainstem hemorrhage (BSH).",[19,20],[32,38,42,46,50,54],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","AI-assisted robotic-guided endoscopic hematoma evacuation","Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Conventional craniotomy","Standard open surgical evacuation of hematoma through craniotomy.",[9],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"AI-assisted robotic-guided puncture and hematoma evacuation","AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.",[28,16],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Standard medical management","Guideline-based conservative therapy without surgical hematoma evacuation.",[28,16],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage","AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.",[22],{"type":33,"name":55,"description":56,"armGroupLabels":57,"otherNames":37},"External ventricular drainage (EVD)","Conventional ventricular catheter placement for hematoma drainage.",[22],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":37,"email":63},"Gao Chen, MD.","CONTACT","+86 0571 87784813","d-chengao@zju.edu.cn",{"name":65,"role":61,"phone":66,"phoneExt":37,"email":67},"Xiaobo Yu, MD.","+86 0571 87784816","blzk2008@zju.edu.cn",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":37},"The Second Affiliated Hospital of Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":78,"coordinates":79},"Point",[80,81],120.16142,30.29365,{"lat":81,"lon":80},{"type":84,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[86,88,90],{"name":87,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":89,"class":6},"Huashan Hospital",{"name":91,"class":6},"China-Japan Friendship Hospital","100608723","rainbow-ich-trial-of-ai-guided-minimally-invasive-neurosurgery-for-ich-100608723",false,"NCT07205263","RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH","A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)","RAINBOW-ICH","Umbrella Trial Inclusion Criteria:\n\n1. Age ≥18 years；\n2. Clinical diagnosis of spontaneous hemorrhagic stroke；\n\nUmbrella Trial Exclusion Criteria:\n\n1\\. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage；\n\nEach substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.","ALL","18 Years",{"count":103,"type":104},1000,"ESTIMATED","INTERVENTIONAL",[107],"NA","Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes.\n\nUnder a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs of different ICH subgroups, thereby supporting a more patient-centered approach to care.",[110,111,112,113],"Basal Ganglia Hemorrhage","Intraventricular Hemorrhage","Brainstem Stroke","Intracranial Hemorrhage, Spontaneous",[115,116,112,117,110,118],"Umbrella Trial","Intraventricular hemorrhage","Robotic-guided","Minimally invasive surgery","2026-01-06",{"date":121,"type":122},"2026-01-08","ACTUAL",{"date":124,"type":122},"2025-09-30",{"date":126,"type":104},"2027-12",{"name":5,"class":6},1]