[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100268436":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":18,"locations":25,"responsibleParty":63,"collaborators":18,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":89,"whyStopped":90,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"HeadSense Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-1000 recording","EXPERIMENTAL","ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.",[13],"Device: HS-1000",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":18},"DEVICE","HS-1000",null,[9],[21],{"name":22,"affiliation":23,"role":24},"Katsuji Shima","National Defense Medical College","PRINCIPAL_INVESTIGATOR",[26,37,42,50,58],{"facility":27,"status":18,"city":28,"state":18,"zip":18,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":18},"Kuki General Hospital","Saitama","Japan","JP",{"type":32,"coordinates":33},"Point",[34,35],139.65657,35.90807,{"lat":35,"lon":34},{"facility":38,"status":18,"city":28,"state":18,"zip":18,"country":29,"countryCode":30,"cosmosGeoPoint":39,"geoPoint":41,"contacts":18},"National Defense Medical College Hospital",{"type":32,"coordinates":40},[34,35],{"lat":35,"lon":34},{"facility":43,"status":18,"city":44,"state":18,"zip":18,"country":29,"countryCode":30,"cosmosGeoPoint":45,"geoPoint":49,"contacts":18},"Juntendo University Shizuoka Hospital","Shizuoka",{"type":32,"coordinates":46},[47,48],138.38333,34.98333,{"lat":48,"lon":47},{"facility":51,"status":18,"city":52,"state":18,"zip":18,"country":29,"countryCode":30,"cosmosGeoPoint":53,"geoPoint":57,"contacts":18},"Nippon Medical School","Tokyo",{"type":32,"coordinates":54},[55,56],139.69171,35.6895,{"lat":56,"lon":55},{"facility":59,"status":18,"city":52,"state":18,"zip":18,"country":29,"countryCode":30,"cosmosGeoPoint":60,"geoPoint":62,"contacts":18},"Tokyo Jikei University Kashiwa Hospital",{"type":32,"coordinates":61},[55,56],{"lat":56,"lon":55},{"type":64,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100268436","an-evaluation-of-non-invasive-icp-monitoring-in-patients-undergoing-invasive-icp-monitoring-via-an-intraparenchymal-pressure-monitoring-device-100268436",false,"NCT02773888","An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device","Inclusion Criteria:\n\n* Male and female subjects, aged 14 years old and over at screening visit\n* Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology\n* Survival expectancy greater than 48 hours\n* Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol\n* Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Subject with ear disease, ear trauma\n* Subject with a punctured or discontinuous dura layer (must be intact)\n* Subject with cerebral fluid (CSF) leakage\n* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials\n* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)\n* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g. mental condition)","ALL","14 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.\n\nHS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.",[81,82,83,84,85],"Intracranial Hypertension","Brain Injuries","Stroke","Hydrocephalus","Brain Neoplasms",[87,88],"intracranial pressure","noninvasive monitoring","SUSPENDED","Recruitment temporarily held for site retraining","2017-02-23",{"date":93,"type":94},"2017-02-27","ACTUAL",{"date":96,"type":18},"2015-12",{"date":98,"type":75},"2017-12",{"name":5,"class":6},5]