[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592875":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":31,"locations":41,"responsibleParty":120,"collaborators":10,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":10,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":10,"enrollmentInfo":131,"targetDuration":10,"studyType":134,"phases":10,"briefSummary":135,"conditions":136,"keywords":10,"overallStatus":101,"whyStopped":10,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"EMVision Medical Devices Ltd","NETWORK",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Intracranial Haemorrhage Group A",null,[12],"Diagnostic Test: Brain Scan",{"label":14,"type":10,"description":15,"interventionNames":16},"Other Group B","Group B includes all patients enrolled in the study ultimately diagnosed with a condition other than intracranial haemorrhage, including ischaemic stroke, transient ischaemic attack, or any of a variety of stroke mimicking conditions.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","Brain Scan","The EMVision emu™ Brain Scanner is a device system which scans the human brain using radiofrequency techniques. The emu™ headset is placed on the head of a patient, enabling ultra-high frequency radio wave (also commonly referred to as microwave) signal propagation into the patient's head.\n\nThe radio-waves reflect from and transmit through the tissue boundaries and are detected by the receiver antennae within the headset. The transceivers operate at very low-level signals in accordance with national and international safety thresholds. The scattered signals carry information on the scanned tissues.",[9,14],[24,28],{"name":25,"affiliation":26,"role":27},"Reade De Leacy, MBBS(Hons) FRANZCR","Associate Professor of Neurosurgery and Radiology Director of Neurointerventional Spine Site Director Cerebrovascular Services Mount Sinai Queens Co-director Neuroendovascular Surgery Fellowship Department of Neurosurgery Mount Sinai Health System","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Angela Dos Santos, PhD","Melbourne Health",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Christian Wight, PhD","CONTACT","61 (0) 490 109 797","cwight@emvision.com.au",{"name":38,"role":34,"phone":39,"phoneExt":10,"email":40},"Sadie Burnham","7742078910","sburnham@vastrax.com",[42,63,80,99],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Mayo Jacksonville","NOT_YET_RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-81.65565,30.33218,{"lat":54,"lon":53},[57,61],{"name":58,"role":34,"phone":59,"phoneExt":10,"email":60},"Ewa Szymkiewicz","904-953-3219","Szymkiewicz.Ewa@mayo.edu",{"name":62,"role":27,"phone":10,"phoneExt":10,"email":10},"William Freeman, PhD",{"facility":64,"status":44,"city":65,"state":66,"zip":67,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"UTHealth","Houston","Texas","77030",{"type":51,"coordinates":69},[70,71],-95.36327,29.76328,{"lat":71,"lon":70},[74,78],{"name":75,"role":34,"phone":76,"phoneExt":10,"email":77},"Glenda Torres","713-500-6153","Glenda.L.Torres@uth.tmc.edu",{"name":79,"role":27,"phone":10,"phoneExt":10,"email":10},"Aaron Gusdon, PhD",{"facility":81,"status":44,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Liverpool Hospital","Liverpool","New South Wales","2170","Australia","AU",{"type":51,"coordinates":88},[89,90],150.92588,-33.91938,{"lat":90,"lon":89},[93,97],{"name":94,"role":34,"phone":95,"phoneExt":10,"email":96},"Jasmeen Khan","0428 292 184","Jasmeen.Khan@health.nsw.gov.au",{"name":98,"role":27,"phone":10,"phoneExt":10,"email":10},"Dennis Cordato, PhD",{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":85,"countryCode":86,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Royal Melbourne Hospital","RECRUITING","Parkville","Victoria","3050",{"type":51,"coordinates":106},[107,108],144.95,-37.78333,{"lat":108,"lon":107},[111,115,117],{"name":112,"role":34,"phone":113,"phoneExt":10,"email":114},"Christine Shin","03 9342 4413","SooJeong.Shin@mh.org.au",{"name":116,"role":27,"phone":10,"phoneExt":10,"email":10},"Angela Dos Santos, MD",{"name":118,"role":119,"phone":10,"phoneExt":10,"email":10},"Steve Davis","SUB_INVESTIGATOR",{"type":121,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100592875","diagnostic-performance-study-of-the-emvision-emu-brain-scanner-in-the-detection-of-intracranial-hemorrhage-in-suspected-stroke-patients-100592875",false,"NCT06999122","Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients","Multi-Center, Prospective, Consecutive, Paired Diagnosis, Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients","Inclusion Criteria:\n\n1. Adults ≥22 years of age\n2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset\n3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient\n4. CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care\n5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -\n\nExclusion Criteria:\n\n1. Has received treatment for current (suspected) stroke event prior to initial CT\u002FMRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)\n2. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and\u002For angiography\n3. Presence of any implanted electro-stimulating devices in the head and neck\n4. Presence of any metallic implants in the cranial vault or surrounding bones\u002Ftissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable)\n5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device\n6. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)\n7. Unable to lie still for the duration of the scan\n8. Pregnant or breastfeeding\n9. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -","ALL","22 Years",{"count":132,"type":133},300,"ESTIMATED","OBSERVATIONAL","The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available.\n\nEMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.",[137,138],"Stroke","Hemorrhagic Stroke","2025-06-12",{"date":141,"type":142},"2025-06-13","ACTUAL",{"date":144,"type":142},"2025-03-26",{"date":146,"type":133},"2026-11-28",{"name":5,"class":6},4]