[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654176":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":38,"armGroups":47,"interventions":65,"overallOfficials":38,"centralContacts":85,"locations":91,"responsibleParty":107,"collaborators":111,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":38,"enrollmentInfo":124,"targetDuration":38,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":137,"overallStatus":145,"whyStopped":38,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Pontificia Universidade Católica do Rio Grande do Sul","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Adenoma Detection Rate (ADR)","Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.","During index colonoscopy.",[14,17,21,24,27,31,34],{"measure":15,"description":16,"timeFrame":12},"Serrated Lesion Detection Rate","Proportion of participants with ≥1 serrated lesion (e.g., sessile serrated lesion or hyperplastic polyp) detected during the first-look withdrawal phase using the allocated imaging modality, with histopathology confirmation when available.",{"measure":18,"description":19,"timeFrame":20},"Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)","Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.","During index colonoscopy with post-procedure histopathology results.",{"measure":22,"description":23,"timeFrame":20},"Agreement Between Optical Diagnosis and Histopathology","Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.",{"measure":25,"description":26,"timeFrame":20},"Concordance of Endoscopic Classifications With Histopathology","Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.",{"measure":28,"description":29,"timeFrame":30},"Interobserver and Intraobserver Agreement From Blinded Video Review","Interobserver and intraobserver agreement (Cohen's kappa) for optical diagnosis and classification based on standardized video recordings of lesions reviewed independently and blinded to group allocation and histopathology.","Up to 12 months after index colonoscopy (video-based assessment).",{"measure":32,"description":33,"timeFrame":12},"Procedure Quality Metrics","Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.",{"measure":35,"description":36,"timeFrame":37},"Safety (Procedure-related Adverse Events)","Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).","Up to 24 hours after colonoscopy.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), or Spectral Flexible Imaging (SFI). Each participant will undergo the first-look withdrawal phase using the imaging modality assigned to their study group","DIAGNOSTIC",{"masking":45,"maskingDescription":38,"whoMasked":38},"NONE","This prospective randomized controlled study will compare high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), and Spectral Flexible Imaging (SFI) for the detection and optical characterization of colorectal lesions during colonoscopy.\n\nParticipants will be randomized in a 1:1:1 ratio to one of the three imaging modalities. During the first-look withdrawal phase, the colon will be examined using the allocated modality. Detected lesions will be documented and characterized in vivo according to their location, size, morphology, and established endoscopic classification systems, including the Paris, Kudo, and JNET classifications. Lesions will subsequently be biopsied or resected as clinically appropriate and submitted for histopathological evaluation, which will serve as the reference standard for diagnostic performance analyses.\n\nStandardized recordings of colorectal lesions will also be used for blinded review to assess interobserver and intraobserver agreement in optical diagnosis and endoscopic classification. In addition to evaluating lesion detection and characterization, the study will compare procedural quality metrics and safety across the imaging modalities.\n\nThe study is designed to determine whether VIST or SFI can improve colorectal lesion detection and optical characterization compared with conventional high-definition white light endoscopy.",[48,54,60],{"label":49,"type":50,"description":51,"interventionNames":52},"White Light Endoscopy (WLE)","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo colonoscopy using high-definition white light endoscopy (WLE) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.",[53],"Device: White Light Endoscopy",{"label":55,"type":56,"description":57,"interventionNames":58},"Versatile Intelligent Staining Technology (VIST)","EXPERIMENTAL","Participants randomized to this arm will undergo colonoscopy using Versatile Intelligent Staining Technology (VIST) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.",[59],"Device: Versatile Intelligent Staining Technology",{"label":61,"type":56,"description":62,"interventionNames":63},"Spectral Flexible Imaging (SFI)","Participants randomized to this arm will undergo colonoscopy using Spectral Flexible Imaging (SFI) during the first-look withdrawal phase. Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol. Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.",[64],"Device: Spectral Flexible Imaging",[66,73,79],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DEVICE","White Light Endoscopy","Colonoscopy performed using high-definition white light imaging.",[49],[72],"WLE",{"type":67,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Versatile Intelligent Staining Technology","Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).",[55],[78],"VIST",{"type":67,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Spectral Flexible Imaging","Colonoscopy performed using Spectral Flexible Imaging (SFI).",[61],[84],"SFI",[86],{"name":87,"role":88,"phone":89,"phoneExt":38,"email":90},"Ari Ben Hur Stefani Leão, MD","CONTACT","+55 51 3195 2843","gpeg.pucrs@gmail.com",[92],{"facility":93,"status":38,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Hospital São Lucas da PUCRS","Porto Alegre","Rio Grande do Sul","90160-090","Brazil","BR",{"type":100,"coordinates":101},"Point",[102,103],-51.23019,-30.03283,{"lat":103,"lon":102},[106],{"name":87,"role":88,"phone":89,"phoneExt":38,"email":90},{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Alexandre Vontobel Padoin","Professor",[112],{"name":113,"class":6},"Hospital Sao Lucas da PUCRS","100654176","evaluation-of-versatile-intelligent-staining-technology-vist-and-spectral-flexible-imaging-sfi-for-detection-and-optical-characterization-of-colorectal-lesions-a-prospective-randomized-controlled-study-100654176",false,"NCT07797361","Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study","Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT Study)","INSIGHT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing screening or surveillance colonoscopy\n* Adequate bowel preparation (Boston Bowel Preparation Scale ≥6, with ≥2 per segment)\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Prior colorectal resection\n* Colorectal stenosis preventing scope progression\n* Pregnancy or breastfeeding\n* Inadequate bowel preparation\n* Clinical contraindication to colonoscopy","ALL","18 Years",{"count":125,"type":126},990,"ESTIMATED","INTERVENTIONAL",[129],"NA","This prospective randomized controlled study aims to evaluate the diagnostic accuracy of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for detection and optical characterization of colorectal lesions during colonoscopy. The performance of VIST and SFI will be compared with high-definition white light endoscopy (WLE), using histopathology as the reference standard and established endoscopic classifications (Paris, Kudo, and JNET). The study will also assess adenoma detection rate, serrated lesion detection, inter- and intraobserver agreement, and procedure-related metrics.",[132,133,134,135,136],"Colorectal Neoplasms","Colonic Polyps","Adenoma","Serrated Polyps","Colorectal Cancer Screening",[138,139,140,141,142,55,61,68,143,144],"Colonoscopy","Adenoma Detection Rate","Optical Diagnosis","Image-Enhanced Endoscopy","Electronic Chromoendoscopy","JNET Classification","Kudo Pit Pattern","NOT_YET_RECRUITING","2026-08-26",{"date":148,"type":149},"2026-09-01","ACTUAL",{"date":151,"type":126},"2026-10-01",{"date":153,"type":126},"2028-08-31",{"name":109,"class":6},1]