[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658289":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":24,"armGroups":22,"interventions":25,"overallOfficials":22,"centralContacts":22,"locations":22,"responsibleParty":29,"collaborators":22,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":22,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":22,"briefSummary":47,"conditions":48,"keywords":22,"overallStatus":50,"whyStopped":22,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":22},{"fullName":5,"class":6},"Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":22},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Accuracy","The percentage of samples in which the artificial intelligence model correctly identifies the corresponding intestinal anatomical sites across all endoscopic video frames, relative to the total sample size enrolled in the study. This metric reflects the overall classification accuracy of the model.","through study completion, an average of 1 year",{"measure":14,"description":15,"timeFrame":12},"Sensitivity","The proportion of all true positive samples annotated as a specific intestinal segment by endoscopy experts that are correctly identified as this segment by the artificial intelligence model. This metric primarily evaluates the model's ability to avoid missed detection of the target anatomical site.",{"measure":17,"description":18,"timeFrame":12},"F1-score","To address the problem of \"class imbalance\" caused by variable colonoscopy examination time across different intestinal segments, this study adopts the F1-score for comprehensive evaluation. The calculation is performed as follows: first, the precision for a specific intestinal segment is obtained; then the harmonic mean of this precision and sensitivity is calculated. To assess overall performance, the arithmetic mean of the F1-scores for all intestinal segment classifications is finally computed (i.e., macro-averaged F1-score).",{"measure":20,"description":21,"timeFrame":12},"Macro-AUC","The receiver operating characteristic (ROC) curve reflects the model's overall discriminative performance under different decision thresholds. For this multi-class classification task, the calculation proceeds as follows: each specific intestinal segment is treated as the positive class one by one; the corresponding ROC curve is plotted and the area under the curve (AUC) is calculated for each segment. Thereafter, the arithmetic mean of AUC values across all anatomical categories is computed to obtain the macro-averaged AUC, which serves as the composite metric for evaluating the overall multi-class discriminative ability of the model.",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":6,"timePerspective":6,"maskingInfo":22},"Participants aged 18-75 years scheduled for colonoscopy, with successful cecal intubation and adequate bowel preparation. Colonoscopic videos are collected to validate an AI system for real-time anatomical site recognition and localization.",[26],{"type":6,"name":27,"description":28,"armGroupLabels":22,"otherNames":22},"Artificial intelligence-based colonoscopic anatomical site recognition system","This artificial intelligence system performs real-time automatic recognition and localization of colorectal anatomical sites and detects the colonoscopic inspection extent during colonoscopy. The model is built with deep convolutional neural networks and validated using endoscopic video frames.",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Xiuli Zuo","Professor, Chief Physician, Department of Gastroenterology","100658289","artificial-intelligence-based-automatic-recognition-and-localization-of-anatomical-sites-in-colonoscopy-100658289",false,"NCT07849881","Artificial Intelligence-Based Automatic Recognition and Localization of Anatomical Sites in Colonoscopy","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female;\n2. Undergoing colonoscopy;\n3. Successful cecal intubation with the endoscope reaching the ileocecal valve;\n4. Adequate colonic cleansing, with a Boston Bowel Preparation Scale (BBPS) score ≥2 points in each of the three colonic segments.\n\nExclusion Criteria:\n\n1. Reduced life expectancy;\n2. Active gastrointestinal bleeding;\n3. History of lower gastrointestinal tract surgery;\n4. Previous history of colorectal cancer or adenomas;\n5. Prior history of sessile serrated polyps greater than 10 mm in diameter;\n6. Ongoing chemotherapy or radiotherapy;\n7. Diagnosis of inflammatory bowel disease;\n8. Intestinal diseases identified during the current examination, including colorectal cancer, colorectal polyps and inflammatory bowel disease;\n9. Pregnant or lactating women, and participants unwilling to use contraception during the study;\n10. Other behaviours that may increase disease risk, such as heavy alcohol consumption and drug abuse;\n11. Participants unable or unwilling to provide written informed consent;\n12. Unclear colonoscopy videos;\n13. Incomplete colonoscopy videos.","ALL","18 Years","75 Years",{"count":43,"type":44},8000,"ESTIMATED","1 Day","OBSERVATIONAL","This study aims to develop, validate and evaluate an artificial intelligence-based system for real-time automatic localization of colorectal anatomical sites during colonoscopy and detection of colonoscopic inspection extent, so as to improve examination quality and the precision of lesion management. The hypothesis of this study is that a colonoscopic image recognition model built on deep convolutional neural networks can accurately extract intestinal anatomical features from endoscopic video frames. In prospective and retrospective independent validation cohorts, the artificial intelligence model is hypothesized to achieve an overall accuracy of no less than 85% for the multi-class anatomical site localization task across colonic segments, with an expected sensitivity of 90% and specificity of 85%. The model predictions are expected to be in high agreement with assessments by senior endoscopists, with an anticipated Kappa coefficient of 0.80. This will verify the technical feasibility and accuracy of deep learning-driven real-time anatomical localization during colonoscopy.",[49],"Colonic Diseases","NOT_YET_RECRUITING","2026-09-24",{"date":53,"type":54},"2026-09-30","ACTUAL",{"date":56,"type":44},"2026-10-01",{"date":58,"type":44},"2028-03-01",{"name":31,"class":6}]