[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559775":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":92,"collaborators":32,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":32,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":32,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":120,"whyStopped":32,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Magentiq Eye LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.","OTHER","Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO.",[13],"Diagnostic Test: MAGENTIQ-COLO.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","MAGENTIQ-COLO.","This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.",[9],[21],"Model: AI-DETECT-GI \u002F AI-DETECT-GI-CU",[23],{"name":24,"affiliation":25,"role":26},"Peter Siersema, MD, Ph.D.","Erasmus Medical Center","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Dror Zur, Ph.D","CONTACT","+972 547 555922",null,"dror@magentiq.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Tal Yerushalmi, MHA","+972 50 2936610","tal@myclinical.net",[39,52,62,73,82],{"facility":40,"status":32,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":32},"Johns Hopkins Hospital","Baltimore","Maryland","21202","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-76.61219,39.29038,{"lat":50,"lon":49},{"facility":53,"status":32,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":32},"Erlanger Health System","Chattanooga","Tennessee","37403",{"type":47,"coordinates":58},[59,60],-85.30968,35.04563,{"lat":60,"lon":59},{"facility":63,"status":32,"city":64,"state":65,"zip":32,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":32},"Assuta","Haifa","Select State","Israel","IL",{"type":47,"coordinates":69},[70,71],34.99928,32.81303,{"lat":71,"lon":70},{"facility":74,"status":32,"city":75,"state":32,"zip":76,"country":66,"countryCode":67,"cosmosGeoPoint":77,"geoPoint":81,"contacts":32},"Hadassah Medical Organization","Jerusalem","91120",{"type":47,"coordinates":78},[79,80],35.21633,31.76904,{"lat":80,"lon":79},{"facility":25,"status":32,"city":83,"state":32,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":32},"Rotterdam","3000 CA","Netherlands","NL",{"type":47,"coordinates":88},[89,90],4.47917,51.9225,{"lat":90,"lon":89},{"type":93,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100559775","study-to-evaluate-the-diagnostic-performance-of-of-magentiq-colo-during-colonoscopy-100559775",false,"NCT06568523","Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.","A Multicenter Study to Evaluate the Diagnostic Performance of Computer-aided Polyp Size Classification of the MAGENTIQ-COLO During Real-time Colonoscopy","Inclusion Criteria:\n\n* Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.\n\nExclusion Criteria:\n\n1. In situ polyps with known histology detected in a previous colonoscopy.\n2. No colorectal polyps detected during colonoscopy.\n3. Known or suspected inflammatory bowel disease.\n4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).\n5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome).\n6. History of chemotherapy or radiation therapy for colorectal lesions.\n7. Pregnancy.\n8. Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.).\n9. Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist.\n10. Inability to provide informed consent.",true,"ALL","45 Years","80 Years",{"count":106,"type":107},330,"ESTIMATED","INTERVENTIONAL",[110],"NA","This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.",[113,114],"Screening Colonoscopy","Surveillance Colonoscopy",[116,117,118,113,114,119],"Colorectal Neoplasms","Intestinal Neoplasms","Digestive System Neoplasms","Automatic Polyp Detection","NOT_YET_RECRUITING","2024-08-21",{"date":123,"type":124},"2024-08-23","ACTUAL",{"date":126,"type":107},"2024-09-15",{"date":128,"type":107},"2025-08-31",{"name":5,"class":6},5]