[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593362":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":29,"responsibleParty":78,"collaborators":24,"id":82,"slug":24,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":24,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":32,"whyStopped":24,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"SCALE-EYE measurement than biopsy-forceps assisted measurement","When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement.",[12],"Device: SCALE-EYE (1)",{"label":14,"type":6,"description":15,"interventionNames":16},"Biopsy-forceps assisted measurement than SCALE-EYE measurement","When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement.",[17],"Device: SCALE-EYE (2)",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","SCALE-EYE (1)","Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement.",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"SCALE-EYE (2)","Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE.",[14],[30,49,64],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Catharina Ziekenhuis","RECRUITING","Eindhoven","North Brabant","5623 EJ","Netherlands",{"type":38,"coordinates":39},"Point",[40,41],5.47778,51.44083,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Ramon-Michel Schreuder, Dr.","CONTACT","+31 40 2399750","ramonmichel.schreuder@catharinaziekenhuis.nl",{"facility":50,"status":32,"city":51,"state":52,"zip":53,"country":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"LUMC","Leiden","South Holland","2333 ZG",{"type":38,"coordinates":55},[56,57],4.49306,52.15833,{"lat":57,"lon":56},[60],{"name":61,"role":46,"phone":62,"phoneExt":24,"email":63},"Jurjen Boonstra, Dr.","+31 71 5263575","j.j.boonstra@lumc.nl",{"facility":65,"status":32,"city":66,"state":52,"zip":67,"country":36,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Erasmus MC","Rotterdam","3015 GD",{"type":38,"coordinates":69},[70,71],4.47917,51.9225,{"lat":71,"lon":70},[74],{"name":75,"role":46,"phone":76,"phoneExt":24,"email":77},"Demi Gerritsen, MSc","+31 650033985","d.gerritsen@erasmusmc.nl",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Peter Siersema","Prof. Dr. P.D. Siersema","100593362",false,"NCT07005453","Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size","Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy","ASSEMBLE","Inclusion Criteria:\n\n* Participants aged 55-80\n* Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy\n* Polyps of all forms ≤25 mm as assessed by the endoscopist\n\nExclusion Criteria:\n\n* No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present\n* Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) \\\u003C2 per segment)\n* Intraprocedural complications, not caused by the study device\n* Known or suspected inflammatory bowel disease (IBD)\n* Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)\n* Ileoanal pouch and anastomosis\n* History of radiation or chemotherapy for colorectal lesions\n* Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))\n* Pregnancy\n* No Informed consent (IC) possible","ALL","55 Years","80 Years",{"count":93,"type":94},241,"ESTIMATED","INTERVENTIONAL",[97],"NA","A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.\n\nSustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.",[100],"Colorectal Polyps",[102,103,104,105],"virtual scale endoscopy","biopsy forceps","optical assessment","colorectal cancer","2026-01-12",{"date":108,"type":109},"2026-01-13","ACTUAL",{"date":111,"type":109},"2025-09-23",{"date":113,"type":94},"2026-04-01",{"name":5,"class":6},3]