[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596176":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The Cooper Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Augmented Reality Assistance","EXPERIMENTAL","Placement of EVDs using augmented reality device",[13],"Device: EVD placement - AR assisted",{"label":15,"type":16,"description":17,"interventionNames":18},"Stealth Image-guided assistance","ACTIVE_COMPARATOR","Placement of EVDs using Stealth image-guidance",[19],"Device: EVD placement - image-guidance assisted",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","EVD placement - image-guidance assisted","During EVD placement, an image-guided noninvasive systems will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of image-guidance system occurs once during initial EVD placement in this trial.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"EVD placement - AR assisted","During EVD placement, an AR system will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of AR occurs once during initial EVD placement in this trial.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Corey Mossop, MD","CONTACT","856-342-2000","mossop-corey@cooperhealth.edu",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Cooper University Health","Camden","New Jersey","08103","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-75.11962,39.92595,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Corey Mossop","Neurosurgeon","100596176","placing-external-ventricular-drains-using-assistive-augmented-reality-or-image-based-localization-100596176",false,"NCT07042048","Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization","Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)","PEARL","Inclusion Criteria:\n\n* adult patient at time of screening\n* diagnosis of spontaneous ICH with IVH with severe TBI\n* Meet one or more of the following clinical or radiographic criteria:\n\nTissue swelling on imaging Dysmorphic ventricles on imaging Midline shift \\>2mm on imaging Mass effect on imaging Evans Index \\\u003C0.3 on imaging Glasgow Coma Scale 3-8\n\n* admitted to Cooper University Health\n* requires an EVD\n\nExclusion Criteria:\n\n* Other concomitant intracranial pathology (e.g., tumor, tumor-related edema\u002Fhemorrhage, congenital condition, etc.)\n* Concurrent participation in another research protocol for investigation of an experimental therapy\n* Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the investigator","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to assess if EVD placement using augmented reality is non inferior to image-guidance systems for assistance in adult patients needing an EVD for spontaneous ICH with IVH or severe TBI. The main question it aims to answer is:\n\nCan EVDs be placed successfully with at least equal safety and efficacy using augmented reality devices in comparison to using standard image-guidance techniques?",[75,76,77],"ICH - Intracerebral Hemorrhage","IVH- Intraventricular Hemorrhage","TBI Traumatic Brain Injury",[79,80,81,82,83],"EVD","Augmented Reality","TBI","ICH","Image Guidance","NOT_YET_RECRUITING","2025-06-25",{"date":87,"type":88},"2025-06-27","ACTUAL",{"date":90,"type":69},"2025-07-01",{"date":92,"type":69},"2026-03-31",{"name":5,"class":6},1]