[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637688":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":30,"overallOfficials":13,"centralContacts":36,"locations":43,"responsibleParty":60,"collaborators":13,"id":62,"slug":13,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":13,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":13,"studyType":74,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Speed and accuracy of STSC","To check the correlation of the accuracy and speed of STSC with the endoscopist's experience profile, the shape of the figure to which STSC is applied and the endoscopist's specialization. The definition of the expected range of tip control speed and accuracy for the different types of endoscopists.\n\nThe definition for the cut-offs for extraordinary and poor tip control. An agreement in the STSC score between different reviewers.","From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"NA","SINGLE_GROUP","The endoscopist will undergo assessment while performing STSC at the edge of a line within an ex vivo model. They will then undergo training and be asked to perform STSC again thereafter for assessment. At least two blinded expert endoscopists will score each video to ensure uniform and unbiased judgment of the participants' technical performance.","HEALTH_SERVICES_RESEARCH",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","At least two blinded expert endoscopists will score each video to ensure uniform and unbiased judgment of the participants' technical performance.","Study Endpoints: Primary endpoints include correlating STSC accuracy and speed with endoscopist expertise profiles, defining expected tip control ranges, and assessing agreement between raters. Secondary endpoints focus on evaluating improvement in tip control following training.\n\nMethods: A prospective trial will be conducted, involving endoscopists of varying experience levels.\n\nParticipants will undergo assessments while performing STSC on the margin of a line within an ex vivo model to simulate a polypectomy defect. The assessments will be video-recorded and anonymized. After the first assessment, the participants will perform a tip control training session on the model before each subsequent assessment. A total of four assessments and three training sessions will be performed. An online application will be used by a pool of 6 expert raters to anonymously rate the videos of the STSC application and calculate the accuracy (number of correct hits over number of wrong hits) and the speed (hits\u002Fsecond) of tip control. No questionaries will be administered to the participants.\n\nStatistical Methods: Statistical analysis will be performed using R software, with data collected and managed in Excel. Pseudonymized data will be stored securely on the hospital server.\n\nConclusion: This study outlines a comprehensive approach to evaluating endoscopist tip control during STSC application. By developing a standardized assessment tool and conducting a prospective trial, the investigators aim to improve our understanding of tip control proficiency and its implications for endoscopic practice.",[24],{"label":25,"type":26,"description":27,"interventionNames":28},"STSC training","EXPERIMENTAL","A free 3D-printed template with dye shapes is used to mark shapes on ham. Endoscopists will then use a snare through the endoscope channel to trace blue-dyed lines with electrosurgical precision.",[29],"Procedure: Ham-based Assessment Model",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":13},"PROCEDURE","Ham-based Assessment Model","Exposure to the HAM model during self-directed learning.",[25],[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Lynn Deleu","CONTACT","93321063","+32","lynn.deleu@uzgent.be",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"UZ Ghent","RECRUITING","Ghent","East-Flanders","9000","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],3.71667,51.05,{"lat":56,"lon":55},[59],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":61,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100637688",false,"NCT07609017","Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)","Inclusion Criteria:\n\n* Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced\u002Finterventional endoscopist)\n* Signed informed consent for study participation\n\nExclusion Criteria:\n\n* No signed informed consent for study participation",true,"ALL","18 Years","65 Years",{"count":72,"type":73},71,"ESTIMATED","INTERVENTIONAL",[15],"Introduction: Colorectal cancer (CRC) is a significant global health concern, with colonoscopy being the primary screening tool for its detection and treatment. Endoscopic techniques such as snare tip soft coagulation (STSC) play a crucial role in reducing adenoma recurrence post-resection. However, assessing endoscopists' proficiency in tip control during these procedures remains challenging. This study aims to develop and validate a web-based scoring system to objectively evaluate endoscopist tip control during STSC application.\n\nResearch Questions:\n\n* Can STSC application on an ex vivo model effectively measure endoscopic tip control across different levels of endoscopists' experience?\n* Is there a correlation between tip control and endoscopists' polypectomy experience?\n* Does tip control vary based on endoscopists' specialization?\n* Can training on the STSC model improve endoscopists' tip control?\n* Is it feasible to train an AI model using videos scored by expert raters to assess tip control?\n* Can tip control be used as an objective measure to predict endoscopists' future performance?\n\nResearch Hypothesis: The investigators hypothesize that developing a model for easy tip control assessment will enable endoscopists to evaluate their proficiency and track progress. Training on the STSC model will enhance tip control, and cut-offs for tip control derived from preliminary data will be refined through this study.",[78],"Evaluating Endoscopist Tip Control During STSC Application",[80,81,82,83,84],"endoscopic tip-control","snare tip soft coagulation (STSC) training model","Ham study endoscopy training","endoscopy STSC tip control","Ham study endoscopy tip control","2026-05-20",{"date":87,"type":88},"2026-05-27","ACTUAL",{"date":90,"type":88},"2024-01-08",{"date":92,"type":73},"2027-06-30",{"name":5,"class":6},1]