[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604180":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":28,"responsibleParty":85,"collaborators":87,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":27,"enrollmentInfo":103,"targetDuration":27,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EndoTEM-System","EXPERIMENTAL","Utilization of the EndoTEM system in the performance of routine endoscopic en bloc resection using endoscopic submucosal dissection.",[13],"Device: EndoTEM resection platform and technique",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","EndoTEM resection platform and technique","EndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions.",[9],[21],"endoscopic portsystem",[23],{"name":24,"affiliation":25,"role":26},"Arthur Schmidt, Prof. Dr. med.","Robert Bosch Krankenhaus GmbH","PRINCIPAL_INVESTIGATOR",null,[29,50,66],{"facility":30,"status":31,"city":32,"state":27,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Universitätsklinikum Freiburg, Klinik für Innere Medizin II","NOT_YET_RECRUITING","Freiburg im Breisgau","79106","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],7.85222,47.9959,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Laura Weber","CONTACT","+49 76127032613","med.2-gi-study@uniklinik-freiburg.de",{"name":49,"role":26,"phone":27,"phoneExt":27,"email":27},"Armin Küllmer, PD. Dr. med.",{"facility":51,"status":31,"city":52,"state":27,"zip":53,"country":34,"countryCode":35,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"RKH Klinikum Ludwigsburg","Ludwigsburg","71640",{"type":37,"coordinates":55},[56,57],9.19161,48.89731,{"lat":57,"lon":56},[60,64],{"name":61,"role":45,"phone":62,"phoneExt":27,"email":63},"Maike Schwidder, Dr. rer. nat.","+497141 99 97543","maike.schwidder@rkh-gesundheit.de",{"name":65,"role":26,"phone":27,"phoneExt":27,"email":27},"Andreas Wannhoff, PD Dr. med",{"facility":25,"status":67,"city":68,"state":27,"zip":69,"country":34,"countryCode":35,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"RECRUITING","Stuttgart","70376",{"type":37,"coordinates":71},[72,73],9.17702,48.78232,{"lat":73,"lon":72},[76,80,84],{"name":77,"role":45,"phone":78,"phoneExt":27,"email":79},"Jasmin Ketel","+49 71181017704","jasmin.ketel@rbk.de",{"name":81,"role":45,"phone":82,"phoneExt":27,"email":83},"Martin Schich, Dr. med.","071181012781","martin.schich@rbk.de",{"name":24,"role":26,"phone":27,"phoneExt":27,"email":27},{"type":86,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[88,91],{"name":89,"class":90},"Ovesco Endoscopy AG","INDUSTRY",{"name":92,"class":93},"Tuebingen Scientific Medical GmbH","UNKNOWN","100604180","clinical-evaluation-of-a-new-platform-for-bi-manual-endoscopic-resection-in-the-rectum-and-sigma-endotem-100604180",false,"NCT07146165","Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM)","EndoTEM","Inclusion Criteria:\n\n* Availability of written informed consent from the patient\n* Age \\> 18 years\n* Adenoma or early carcinoma \\> 2 cm in the rectum or distal sigmoid colon with indication for endoscopic en bloc resection using endoscopic submucosal dissection\n\nExclusion Criteria:\n\n* Informed consent not possible (e.g., language barrier)\n* Stenoses or fistulas in the anal region\n* Distance to the anocutaneous line ≤ 2 cm\n* Distance to the anocutaneous line \\> 20 cm\n* Individual medical assessment required for patients taking anticoagulant medication, in accordance with current ESGE guidelines\n* Pregnancy or breastfeeding\n* Vulnerable individuals","ALL","18 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"NA","The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe.\n\nThe main questions it aims to answer are:\n\n* Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon feasible (i.e., does it enable complete resection of the polyp)?\n* Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon safe?\n\nParticipants will:\n\n* be treated with the EndoTEM system during the endoscopic submucosal dissection of polyps in the distal colon.\n* answere questionnaires on fecal continence and quality of life before and after the intervention.\n* be treated following standard clinical procedures before, during and after the endoscopic removal.",[111,112],"Adenoma Colon Polyp","Adenoma Colon",[114,115,116,21,117],"endoscopic submucosal dissection","endoscopic en bloc resection","EndoTEM system","ESD","2026-03-30",{"date":120,"type":121},"2026-03-31","ACTUAL",{"date":123,"type":121},"2025-10-02",{"date":125,"type":105},"2028-08",{"name":5,"class":6},3]