[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634997":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":10,"responsibleParty":39,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":10},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IBD",null,"Adult patients with established inflammatory bowel disease (ulcerative colitis or Crohn's disease involving the colon) who are undergoing colonoscopy for clinical reasons, will be invited to participate. We will include patients across the spectrum of disease activity (remission to active inflammation) to capture a broad range of mucosal permeability patterns. Approximately 60 IBD participants will be enrolled at the three sites, representing both major IBD subtypes and varying disease distribution",[13],"Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-IBD","An additional 10 non-IBD controls undergoing routine CRC screening or surveillance will be included.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping","This is an observational study, and participants are not assigned a therapeutic intervention as part of the research. All participants will undergo a clinically indicated colonoscopy as part of routine care. As part of the study procedures, colonoscopy will be supplemented with intravenous sodium fluorescein, wide-field fluorescence imaging during scope withdrawal, and AI-assisted video recording and analysis to assess mucosal permeability. In addition, targeted research biopsies will be collected from selected colonic regions for histologic assessment, and at the McMaster site a subset of biopsies will also undergo ex vivo Ussing chamber permeability testing.",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Premysl Bercik, MD","Hamilton Health Sciences, McMaster University","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Liam Rondeau, PhD","CONTACT","905-521-2100","22060","rondeaul@mcmaster.ca",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Melanie AM Wolfe, MLA-T,CCRP","wolfe@hhsc.ca",{"type":28,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Premsyl Bercik","Professor",[43],{"name":44,"class":6},"McMaster University","100634997","ai-enhanced-wide-field-endoscopic-fluorescence-mapping-of-gastrointestinal-mucosal-permeability-in-ibd---a-pilot-study-in-ibd-patients-and-controls-100634997",false,"NCT07546955","AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Able to provide written informed consent\n* Established ulcerative colitis or Crohn's disease involving the colon, or non-IBD control undergoing screening\u002Fsurveillance colonoscopy\n* Undergoing clinically indicated colonoscopy\n* Ability to comply with study procedures\n\nExclusion Criteria:\n\n* Allergy to fluorescein\n* Colorectal cancer\n* Advanced polyps or malignant lesions identified during colonoscopy\n* Significant cardiopulmonary disease\n* Renal failure\n* Active infection or sepsis\n* Severe IBD flare\n* Use of medications that may affect gut permeability, including NSAIDs or antibiotics\n* Inability to tolerate bowel preparation or safely complete the protocol\n* Pregnancy or breastfeeding\n* Inability or unwillingness to provide informed consent or comply with study procedures","ALL","18 Years",{"count":54,"type":55},70,"ESTIMATED","OBSERVATIONAL","This pilot study will test a new imaging system that uses fluorescent dye and artificial intelligence (AI) during colonoscopy to measure how \"leaky\" the lining of the colon is in people with inflammatory bowel disease (IBD). The study will include 70 adults at 3 Canadian hospitals: 60 people with ulcerative colitis or Crohn's disease affecting the colon, and 10 people without IBD who are having colonoscopy for routine colorectal cancer screening or surveillance. During the colonoscopy, participants will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn. The main goal is to find out whether this method can be used safely during routine colonoscopy and whether it can produce usable measurements of mucosal permeability. The study will also examine whether these measurements are related to standard measures of inflammation seen during endoscopy, in biopsy samples, and in ex vivo Ussing chamber testing at the McMaster site. The control group will help define what normal fluorescence and permeability look like. This study is intended to provide early data on whether this approach could become a useful new way to assess barrier dysfunction in IBD.",[59,60],"Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)","NON-IBD",[62,15],"IBD, CD, UC","NOT_YET_RECRUITING","2026-04-17",{"date":66,"type":67},"2026-04-23","ACTUAL",{"date":69,"type":55},"2026-04-01",{"date":71,"type":55},"2027-02-01",{"name":5,"class":6}]