[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571064":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":41,"locations":51,"responsibleParty":75,"collaborators":18,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Polyp size measurement with Artificial intelligence (AI)","EXPERIMENTAL","Colonoscopies will be performed according to the standard of care. Patients will have colonoscopies performed using the computer-aided measuring (CAM) system. All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.",[13],"Diagnostic Test: Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system",{"label":15,"type":16,"description":17,"interventionNames":18},"Polyp size measurement without AI","NO_INTERVENTION","Colonoscopies will be performed according to the standard of care without the CAM system. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually and non-scaled device (open biopsy forceps or snare). All measured fresh polyp specimens will be immediately sized in vitro as the ground truth.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Polyp size measurement using autonomous AI measurement or AI-assisted human measurement with the CAM system","The study of real-time polyp size measurement using the CAM system will be conducted in two phases. Phase I (pilot phase, n=24 polyps, about 27 patients) will be used to assess the feasibility of applying the CAM system in real-time in a clinical video in order to obtain pilot data on the relative accuracy of assessing polyp sizes using autonomous AI measurement and AI-assisted human measurement and to determine the relative accuracy of assessing polyp size in Phase II of the study ( Randomized Controlled Trial) to assess the sample size and reference standards for the CAM system. The sample size for the second phase of the randomized controlled trial (comparing AI-assisted human measurement to non-scaled device) will be based on pilot data in order to compare the relative accuracy of polyp size measurement with AI-assisted human measurement versus non-scaled device in clinical practice.",[9],[26],"Polyp size measurement with the CAM system",[28,32,35,38],{"name":29,"affiliation":30,"role":31},"Sheng-Bing Zhao, MD","Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":34},"Yu Bai, MD","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":34},"En-Da Yu, MBBS","Department of Colorectal Surgery and Gastrointestinal Endoscopy Center, Changhai hospital, Naval Medical University, Shanghai 200433, China.",{"name":39,"affiliation":30,"role":40},"Zhao-Shen Li, MD, PhD","STUDY_CHAIR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":18,"email":46},"Cheng-Long Wang, MD","CONTACT","+86-18257806772","sunshinewangcl@126.com",{"name":48,"role":44,"phone":49,"phoneExt":18,"email":50},"Xiang-Yu Sui, MD","+86-19916549745","sui.xiangyu@hotmail.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Changhai Hospital, Naval Medical University","RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":61,"coordinates":62},"Point",[63,64],121.45806,31.22222,{"lat":64,"lon":63},[67,68,69,71,72,73],{"name":43,"role":44,"phone":45,"phoneExt":18,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":18,"email":50},{"name":29,"role":70,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":33,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":36,"role":31,"phone":18,"phoneExt":18,"email":18},{"name":74,"role":31,"phone":18,"phoneExt":18,"email":18},"Zhao-Shen Li, MD",{"type":31,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Zhaoshen Li","Director of Gastroenterology Dept and Digestive Endoscopy Center","100571064","evaluation-of-a-cam-system-for-colorectal-polyp-size-measurement-100571064",false,"NCT06715384","Evaluation of a CAM System for Colorectal Polyp Size Measurement","Performance Evaluation of a Computer-aided Measuring System for Colorectal Polyp Size Measurement: a Prospective Study","CAM","Inclusion Criteria:\n\n1. Adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status.\n2. Colonoscopy screening, surveillance, or diagnostic participants.\n3. Informed consent obtained.\n\nExclusion Criteria:\n\n1. Anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy.\n2. Inflammatory bowel disease.\n3. Aronchick score \\>3 at entry.\n4. Incomplete Case Report Form (CRF) data.\n5. Emergency colonoscopy.\n6. Pregnancy or lactation.\n7. Gastrointestinal obstruction.\n8. Refusal to participate.","ALL","18 Years","85 Years",{"count":90,"type":91},168,"ESTIMATED","INTERVENTIONAL",[94],"NA","Accurate polyp size measurements are essential for risk stratification, selection of polypectomy techniques, and surveillance interval assignments. Evidence indicated that the clinical implementation of artificial intelligence is an optimal tool to improve the measurement of polyps during colonoscopy. This study aimed to evaluate the performance of a computer-aided measuring (CAM) system (EndoDASS) and compare its accuracy with routine sizing methods during real-time colonoscopy.",[97,98],"Colorectal Polyp","Colorectal Adenoma",[100,101,102,103,104],"Artificial Intelligence","Polyp Size","Deep Learning","Colonoscopy","Depth Map","2025-02-15",{"date":107,"type":108},"2025-02-19","ACTUAL",{"date":110,"type":108},"2024-12-15",{"date":112,"type":91},"2025-04-30",{"name":5,"class":6},1]