[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":67,"collaborators":25,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Helios Kliniken Schwerin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Training in presence","ACTIVE_COMPARATOR","The instructor teaches the trainee in physical presence during the ERCP",[13],"Other: Training in presence of the instructor",{"label":15,"type":16,"description":17,"interventionNames":18},"Telemedical training","EXPERIMENTAL","The instructor teaches the trainee telemedically by using smartglasses during the ERCP",[19],"Other: Telemedically training by an instructor",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Training in presence of the instructor","The instructor gives the trainee instructions for the examination while he\u002Fshe is present in the examination room.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Telemedically training by an instructor","The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses",[15],[31],{"name":32,"affiliation":5,"role":33},"Daniel Schmitz, Dr.med.","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Daniel Schmitz, Dr. med.","CONTACT","+49-385-520-2601","daniel.schmitz@helios-gesundheit.de",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Martin Kliment, Dr.med.","Martin.Kliment@helios-gesundheit.de",[44],{"facility":5,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Schwerin","Mecklenburg-Vorpommern","19055","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],11.41316,53.62937,{"lat":54,"lon":53},[57,61,64,65],{"name":58,"role":37,"phone":59,"phoneExt":25,"email":60},"Jörg-Peter Ritz (Medical director of the whole hospital), Prof. Dr. med.","+49-385-520-2050","Joerg-Peter.Ritz@helios-gesundheit.de",{"name":62,"role":37,"phone":59,"phoneExt":25,"email":63},"Jens Nürnberger, Prof. Dr. med.","jens.nuernberger@helios-gesundheit.de",{"name":32,"role":37,"phone":25,"phoneExt":25,"email":25},{"name":66,"role":37,"phone":25,"phoneExt":25,"email":25},"Stefan Prax, Dr.med.",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. med. Daniel Schmitz","Head physician of the Department of Gastroenterology","100568629","smartglass-guided-ercp-with-cannulation-of-native-papilla-10-100568629",false,"NCT06683716","SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0","Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography","EmeRald","Inclusion criteria\n\n* Adult patients aged ≥ 18 years without previous papillotomy Exclusion criteria\n* Cannulation of the minor papilla necessary\n* Significant comorbidity\n* Haemodynamic instability\n* Pregnant women\n* Refusal or inability to give written informed consent for the study\n* Instructor had to perform the examination himself\u002Fherself","ALL","18 Years",{"count":81,"type":82},170,"ESTIMATED","INTERVENTIONAL",[85],"NA","The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds\u002Fminutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).",[88,89],"Biliary Tract Diseases","Pancreatic Diseases",[91,92,93],"Telemedicine","Training Technique","Cholangiopancreatography, Endoscopic Retrograde","NOT_YET_RECRUITING","2024-11-08",{"date":97,"type":98},"2024-11-12","ACTUAL",{"date":100,"type":82},"2025-01-02",{"date":102,"type":82},"2026-12-31",{"name":5,"class":6},1]