[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519315":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":69,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":31,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":31,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Istituto Clinico Humanitas","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Arm CADe","ACTIVE_COMPARATOR","Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.",[13],"Device: Standard, high-definition colonoscopy with the use of CADe assistance",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard Arm CADe\u002FCADx","Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.",[18],"Device: Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance, no leave-in-situ",{"label":20,"type":21,"description":22,"interventionNames":23},"Leave-In-Situ Arm","EXPERIMENTAL","Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).\n\nPolyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.",[24],"Device: Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance, leave-in-situ",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Standard, high-definition colonoscopy with the use of CADe assistance","All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.",[9],null,{"type":27,"name":33,"description":29,"armGroupLabels":34,"otherNames":31},"Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance, no leave-in-situ",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Standard, high-definition colonoscopy with the use of CADe\u002FCADx assistance, leave-in-situ","Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":31,"email":44},"Cesare Hassan","CONTACT","02-82247385","cesare.hassan@hunimed.eu",[46,59],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":31},"RECRUITING","Rozzano","Milano","20089","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],9.1559,45.38193,{"lat":57,"lon":56},{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},{"type":54,"coordinates":61},[56,57],{"lat":57,"lon":56},[64,67],{"name":65,"role":42,"phone":66,"phoneExt":31,"email":44},"Cesare Hassan, Prof\u002FMD","0039-02-82247385",{"name":41,"role":68,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100519315","artificial-intelligence-to-implement-cost-saving-strategies-for-colonoscopy-screening-based-on-in-vivo-prediction-of-polyp-histology-100519315",false,"NCT06041945","Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology","Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology","SAVE","Inclusion Criteria:\n\n* All \\>40 years-old patients undergoing colonoscopy for selected indications\n\nExclusion Criteria:\n\n* patients with personal history of CRC, or IBD\n* patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.\n* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \\\u003C2 in any colonic segment).\n* patients with previous colonic resection.\n* patients on antithrombotic therapy, precluding polyp resection.\n* patients who were not able or refused to give informed written consent.",true,"ALL","40 Years",{"count":83,"type":84},1800,"ESTIMATED","INTERVENTIONAL",[87],"NA","This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.",[90],"Colonic Neoplasms","2023-10-03",{"date":93,"type":94},"2023-10-04","ACTUAL",{"date":96,"type":94},"2023-09-21",{"date":98,"type":84},"2027-09-01",{"name":5,"class":6},2]