[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"David KARSENTI\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100640173",false,"NCT07620080","EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis","Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS","EYE\u002FSPY","Inclusion Criteria:\n\n* 1\\. Adult patients aged 18 to 84 years\n* 2\\. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture\n* 3\\. Absence of a mass easily accessible to EUS-guided fine needle aspiration\n* 4\\. ASA physical status 1-3\n* 5\\. No participation in another clinical trial\n* 6\\. Written informed consent obtained\n* 7\\. Patient affiliated with a social security system or equivalent\n\nExclusion Criteria:\n\n* 1\\. Lithiasic biliary obstruction\n* 2\\. Patients younger than 18 years\n* 3\\. ASA 4 or ASA 5 patients\n* 4\\. Pregnant or breastfeeding women\n* 5\\. Coagulation disorders preventing biopsy procedures\n* 6\\. Surgical anatomy preventing papillary access\n* 7\\. Patients unable to provide informed consent\n* 8\\. Upper gastrointestinal obstruction\n* 9\\. Intolerance to endoscopy\n* 10\\. Severe cardiopulmonary disease\n* 11\\. Acute pancreatitis or severe cholangitis\n* 12\\. Severe contrast agent allergy\n* 13\\. Patients under legal protection measures","ALL","18 Years","84 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.\n\nThe EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.\n\nThe primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.",[27,28],"Cholangiocarcinoma","Biliary Stricture",[30,31,32,33,34,35],"Cholangioscopy","ERCP","EYEMAX","SpyGlass DS","Biliary biopsy","Cholangiocarcinoma diagnosis","NOT_YET_RECRUITING","2026-05-26",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":21},"2026-09",{"date":44,"type":21},"2030-09",{"name":46,"class":47},"David KARSENTI","OTHER",""]