[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602742":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":59,"centralContacts":74,"locations":82,"responsibleParty":164,"collaborators":166,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":29,"eligibilityCriteria":178,"healthyVolunteers":179,"sex":180,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":29,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":29,"overallStatus":128,"whyStopped":29,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Evergreen General Hospital, Taiwan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Clinically significant serrated lesion (CSSL) detection rate","Percentage of patients who have 1 or more histologically confirmed CSSLs, including sessile serrated lesions, traditional serrated adenomas, hyperplastic polyps measuring ≥10 mm anywhere in the colon, or hyperplastic polyps measuring 6-9 mm in the proximal colon (cecum to splenic flexure).","One week (after the colonoscopy procedure, when pathology report is released)",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Sessile serrated lesion (SSL) detection rate","Percentage of patients who have 1 or more histologically confirmed SSL with or without dysplasia.",{"measure":18,"description":19,"timeFrame":12},"Proximal serrated lesion detection rate","Percentage of patients who have 1 or more histologically confirmed proximal serrated lesions, including sessile serrated lesion, translational serrated adenoma, and hyperplastic polyp. The proximal colon includes the cecum, ascending colon, hepatic flexure, transverse colon, and splenic flexure.",{"measure":21,"description":22,"timeFrame":12},"High-risk neoplasm detection rate","Percentage of patients who have 1 or more histologically confirmed advanced adenoma, or ≥5 low-risk adenomas (defined as 1 to 2 tubular adenomas \\\u003C10 mm with low-grade dysplasia), or any serrated lesions ≥10 mm or with dysplasia. Advanced adenomas are defined as those adenomas meeting at least one of the following criteria: (1) size ≥10 mm, (2) presence of 25% villous components, and (3) high-grade dysplasia.",{"measure":24,"description":25,"timeFrame":12},"Adenoma detection rate","Percentage of patients who have 1 or more histologically confirmed conventional adenomas.",{"measure":27,"description":28,"timeFrame":12},"Adenoma per colonoscopy","Total number of histologically confirmed adenomas divided by the total number of colonoscopies.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","SCREENING",{"masking":35,"maskingDescription":29,"whoMasked":36},"DOUBLE",[37,38],"PARTICIPANT","OUTCOMES_ASSESSOR","This will be a multicenter, unblinded investigators, prospective randomized controlled trial (RCT). Randomization (1:1 to WEAID alone and WEAID plus LCI) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WEAID, WEAID-LCI) to see which one is better at detecting CSSL.\n\nPatient recruitment will be conducted at 4 hospitals: University of Montreal Medical Center (CHUM), Quebec, Canada; Evergreen General Hospital, Taoyuan, Taiwan; King Chulalongkorn Memorial Hospital, Bangkok, Thailand; and Ospedale Valduce, Como, Italy. The study period is expected to be 2 years (from August 2025 to July 2027).\n\nPatients aged 40-80 y\u002Fo at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and indication of colonoscopy (screening, surveillance, diagnostic, or positive FIT or gFOBT result). Mode of sedation will include no sedation, on-demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences.\n\nThe study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm). The ELUXEO 7000 system (Fujifilm) will be used. The same endoscopist performs the insertion and withdrawal of colonoscopy. The colonoscope will be inserted with WE method, instead of air insufflation. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water.\n\nControl Method: One arm of the study will include CADe as the control method. The CADe system will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp.\n\nStudy method: The other arm entails the addition of a commercially available image-enhanced LCI technique (Fujifilm) to the CADe system. LCI will be activated during the withdrawal phase to enhance visualization of the lesions.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Water exchange with AI-assisted detection","ACTIVE_COMPARATOR","The study employs standard high-definition colonoscopy video processors with integrated CADe system (CAD-EYE, EW10-EC02, Fujifilm) The ELUXEO 7000 system (Fujifilm) will be used in this study. During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe device will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe systems, ensuring readiness before study initiation.",[46],"Device: Water exchange with AI-assisted detection",{"label":48,"type":49,"description":50,"interventionNames":51},"Water exchange with AI-assisted detection and LCI","EXPERIMENTAL","The study employs high-definition colonoscopy video processors with integrated CADe (CAD-EYE, EW10-EC02, Fujifilm) and LCI systems (Fujifilm).The ELUXEO 7000 system will be used . During the insertion phase of water exchange (WE) colonoscopy, the air pump will be turned off, and the colon will be irrigated with warm water, using a flushing pump. WE involves simultaneous infusion of distilled water to facilitate luminal expansion and suction of unclean water. Withdrawal will begin with the patient in the left lateral position. Consistent techniques, ensuring adequate luminal distention and comprehensive fold examination, will be used. The CADe and LCI devices will be activated during the withdrawal phase of the procedures, and it will provide real-time output in the form of a bounding box whenever the CADe device identifies a suspected polyp. All participating endoscopists possess experience and expertise in CADe and LCI systems, ensuring readiness before study initiation.",[52],"Device: Water exchange with AI-assisted detection and LCI",[54,57],{"type":55,"name":42,"description":44,"armGroupLabels":56,"otherNames":29},"DEVICE",[42],{"type":55,"name":48,"description":50,"armGroupLabels":58,"otherNames":29},[48],[60,64,68,71],{"name":61,"affiliation":62,"role":63},"Chi-Liang Cheng, MD","Evergreen General Hospital, Taoyuan","STUDY_CHAIR",{"name":65,"affiliation":66,"role":67},"Rungsun Rerknimitr, MD","Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology, King Chulalongkorn Memorial Hospital","PRINCIPAL_INVESTIGATOR",{"name":69,"affiliation":70,"role":67},"Daniel von Renteln, MD","Research, Gastroenterology Division, University of Montreal Medical Center (CHUM)",{"name":72,"affiliation":73,"role":67},"Franco Radaelli, MD","Gastroenterology Unit, Ospedale Valduce",[75,79],{"name":61,"role":76,"phone":77,"phoneExt":29,"email":78},"CONTACT","+886 919 768058","chiliang.cheng@gmail.com",{"name":65,"role":76,"phone":80,"phoneExt":29,"email":81},"+66 81 902 6633","ERCP@live.com",[83,110,126,146],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"University of Montreal Medical Center (CHUM)","NOT_YET_RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":92,"coordinates":93},"Point",[94,95],-73.58781,45.50884,{"lat":95,"lon":94},[98,102,105,107,109],{"name":69,"role":76,"phone":99,"phoneExt":100,"email":101},"5148908000","30912","daniel.von.renteln.med@ssss.gouv.qc.ca",{"name":103,"role":104,"phone":29,"phoneExt":29,"email":29},"Roupen Djinbachian, MD","SUB_INVESTIGATOR",{"name":106,"role":104,"phone":29,"phoneExt":29,"email":29},"Simon Bouchard, MD",{"name":108,"role":104,"phone":29,"phoneExt":29,"email":29},"Jeremy Liu Chen Kiow, MD",{"name":69,"role":67,"phone":29,"phoneExt":29,"email":29},{"facility":111,"status":85,"city":112,"state":29,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Ospedale Valduce","Como","22100","Italy","IT",{"type":92,"coordinates":117},[118,119],9.0832,45.80819,{"lat":119,"lon":118},[122,125],{"name":72,"role":76,"phone":123,"phoneExt":29,"email":124},"+39 031 324171","francoradaelli01@gmail.com",{"name":72,"role":67,"phone":29,"phoneExt":29,"email":29},{"facility":127,"status":128,"city":129,"state":29,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Evergreen General Hospital","RECRUITING","Taoyuan","320","Taiwan","TW",{"type":92,"coordinates":134},[135,136],121.29696,24.99368,{"lat":136,"lon":135},[139,141,143,145],{"name":61,"role":76,"phone":140,"phoneExt":29,"email":78},"0919768058",{"name":142,"role":104,"phone":29,"phoneExt":29,"email":29},"Yen-Lin Kuo, MD",{"name":144,"role":104,"phone":29,"phoneExt":29,"email":29},"I-Chia Su, MD",{"name":61,"role":67,"phone":29,"phoneExt":29,"email":29},{"facility":147,"status":85,"city":148,"state":29,"zip":149,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"King Chulalongkorn Memorial Hospital","Bangkok","10330","Thailand","TH",{"type":92,"coordinates":153},[154,155],100.50144,13.75398,{"lat":155,"lon":154},[158,159,161,163],{"name":65,"role":76,"phone":80,"phoneExt":29,"email":81},{"name":160,"role":104,"phone":29,"phoneExt":29,"email":29},"Piyapoom Pakvisal, MD, Msc",{"name":162,"role":104,"phone":29,"phoneExt":29,"email":29},"Krittaya Mekritthikrai, MD",{"name":65,"role":67,"phone":29,"phoneExt":29,"email":29},{"type":165,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[167,169,170],{"name":168,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)",{"name":147,"class":6},{"name":171,"class":6},"Valduce Hospital","100602742","computer-aided-water-exchange-colonoscopy-with-and-without-linked-color-imaging-for-detection-of-clinically-significant-serrated-lesions-100602742",false,"NCT07127471","Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions","A Multicenter Prospective Randomized Controlled Trial of Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions in Computer-Aided Water Exchange Colonoscopy","Inclusion Criteria:\n\n* Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.\n\nExclusion Criteria:\n\n* familial adenomatous polyposis and hereditary non-polyposis CRC syndrome\n* personal history of serrated polyposis syndrome\n* personal history of CRC\n* history of inflammatory bowel disease\n* previous colonic resection\n* overt gastrointestinal bleeding\n* emergency colonoscopy or inpatients\n* planned EMR or ESD of large polyps\n* colon stricture or obstruction\n* contraindications to colonoscopy (eg, acute diverticulitis or toxic megacolon)\n* antithrombotic therapy precluding complete polyp resection\n* American Society of Anesthesiology classification of physical status \\>3\n* pregnant women or women planning pregnancy\n* refusal to provide a written informed consent",true,"ALL","40 Years","80 Years",{"count":184,"type":185},1090,"ESTIMATED","INTERVENTIONAL",[188],"NA","The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.",[191,192,193,194],"Sessile Colonic Polyp","Serrated Lesion","Sessile Serrated Lesion","Colon Adenomas","2026-09-08",{"date":197,"type":198},"2026-09-09","ACTUAL",{"date":200,"type":198},"2025-11-17",{"date":202,"type":185},"2027-12-31",{"name":5,"class":6},4]