[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625057":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":148,"collaborators":150,"id":156,"slug":32,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":32,"enrollmentInfo":165,"targetDuration":32,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":181,"whyStopped":32,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Trans-Duodenal Concepts GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with endoscopic implant of the investigational device","EXPERIMENTAL","The decive will be implanted under sedation with the help of a standard flexible gastroscope. By filling the ringlike ballons with 62 ccm saline solution it will be fixed at the gastric oulet.\n\nAfter 6 months it will be removed by puncture and evacuation of the ballons and removal with a standard foreighn body forceps.",[13],"Device: endoscopic implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","endoscopic implant","The implant will be placed under sedation with the help of an standard flexible gastroscope. It will be fixed by fluid injection into ringlike ballons and place the device at the gastric outlet.\n\nAfter 6 months it will be removed by punction and evacuation of the ballons and extraction with a standard endoscopy foreighn body grasper.",[9],[21],"gastroduodenal bypass liner",[23],{"name":24,"affiliation":25,"role":26},"Christoph Reissfelder, MD Prof.","University of Heidelberg, Medical Center Mannheim, Surgical Department","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Georg Kähler, MD, Prof.","CONTACT","+491797347734",null,"georg.kaehler@transduodenal.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Sabrina Rohrer, PhD","+49707198979133","sabrina.rohrer@novineon.com",[39,56,71,85,100,115,124,134],{"facility":40,"status":32,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Universitätsmedizin Mannheim","Mannheim","Baden-Wurttemberg","68167","Germany",{"type":46,"coordinates":47},"Point",[48,49],8.46694,49.4891,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":54,"phoneExt":32,"email":55},"Niki Taebi, B.Sc.","+496213834864","niki.taebi@umm.de",{"facility":57,"status":32,"city":58,"state":59,"zip":60,"country":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Sozialstiftung Bamberg","Bamberg","Bavaria","96049",{"type":46,"coordinates":62},[63,64],10.90067,49.89873,{"lat":64,"lon":63},[67],{"name":68,"role":30,"phone":69,"phoneExt":32,"email":70},"Felix Gundling, MD, Prof.","+49951 503-13713","felix.gundling@sozialstiftung-bamberg.de",{"facility":72,"status":32,"city":73,"state":59,"zip":74,"country":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Universitätsklinikum Würzburg","Würzburg","97080",{"type":46,"coordinates":76},[77,78],9.95121,49.79391,{"lat":78,"lon":77},[81],{"name":82,"role":30,"phone":83,"phoneExt":32,"email":84},"Markus Brand, MD, PhD","+4993120140931","Brand_M@ukw.de",{"facility":86,"status":32,"city":87,"state":88,"zip":89,"country":44,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik","Bochum","North Rhine-Westphalia","44892",{"type":46,"coordinates":91},[92,93],7.21648,51.48165,{"lat":93,"lon":92},[96],{"name":97,"role":30,"phone":98,"phoneExt":32,"email":99},"Ali Canbay, MD, Prof.","+4923429983416","ali.canbay@ruhr-uni-bochum.de",{"facility":101,"status":32,"city":102,"state":103,"zip":104,"country":44,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Städtisches Klinikum Dresden","Dresden","Saxony","01067",{"type":46,"coordinates":106},[107,108],13.73832,51.05089,{"lat":108,"lon":107},[111],{"name":112,"role":30,"phone":113,"phoneExt":32,"email":114},"Matthias Kandler, MD","+493518562170","matthias.kandler@klinikum-dresden.de",{"facility":116,"status":32,"city":117,"state":103,"zip":118,"country":44,"cosmosGeoPoint":119,"geoPoint":123,"contacts":32},"University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology","Leipzig","04103",{"type":46,"coordinates":120},[121,122],12.37129,51.33962,{"lat":122,"lon":121},{"facility":125,"status":32,"city":117,"state":103,"zip":126,"country":44,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Klinikum St. Georg Leipzig","04129",{"type":46,"coordinates":128},[121,122],{"lat":122,"lon":121},[131],{"name":132,"role":30,"phone":133,"phoneExt":32,"email":32},"Ingolf Schiefke, MD, Prof.","+493419094312",{"facility":135,"status":32,"city":136,"state":32,"zip":137,"country":44,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Charite Universitätmedizin Berlin CVK","Berlin","13353",{"type":46,"coordinates":139},[140,141],13.41053,52.52437,{"lat":141,"lon":140},[144],{"name":145,"role":30,"phone":146,"phoneExt":32,"email":147},"Konstantinos Kouladouros, MD PhD","+4930450665318","konstantinos.kouladouros@charite.de",{"type":149,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[151,154],{"name":152,"class":153},"novineon CRO GmbH","UNKNOWN",{"name":155,"class":153},"VDI Technologiezentrum","100625057",false,"NCT07417683","Multicentric Approval Study Trans-Duodenal Barrier for Typ 2 Diabetes With Obesity","Leistung Und Sicherheit Des Trans-Duodenal Barrier (LuST)","LuST","Inclusion Criteria:\n\n* Obese patients with type 2 diabetes mellitus,\n* Age ≥ 18 years,\n* The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28),\n* The patient has been informed and all written consents from the patient are available.\n\nExclusion Criteria:\n\n* The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial.\n* The patient is unwilling or unable to follow postoperative instructions.\n* The patient has been placed in an institution by court order or official order (MPDG §27).\n* The patient lives more than 100 km from the treatment site.\n* Pregnancy.\n* The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.","ALL","18 Years",{"count":166,"type":167},126,"ESTIMATED","INTERVENTIONAL",[170],"NA","Approval study Trans-Duodenal Barrier The goal of this clinical trial is to determin the safety and performance of the newly developed Trans-Duodenal Barrier in adult Tryp 2 diabetic and obese patients.\n\nThe Trans-Duodenal Barrier is an endoscopic implant which can be placed to the gastric outlet and the upper small bowel by interventional endoscopy. It consists of a 60 cm long foil tube , a transpyloric shaft and and two ringlike balloons to fix it at the pylorus. It will be removed after 6 months via gastroscopy.\n\nThe main questions it aims to answer are:\n\n* Does the Trans-Duodenal Barrier lower the HbA1c of the participants ?\n* How frequent are adverse side effects related to the device?\n* How much ist the excessive wight loss of treated patients ?\n* Show patients with Metabolic assiociated Hepatosteatitis (MASH) improvements in liver elasticity (elastography) ? Researchers implant the Trans-Duodenal Barrier to enclosed patients and follow up them till 4 weeks after explantation.\n\nParticipants will:\n\n* Get the Trans-Duodenal Barrier as an implant for 6 moths\n* Visit the clinic 3 times in the implant period and once for explant.\n* Receive a telefon interview 4 weeks after explant",[173,174,175,176],"Typ 2 Diabetes","Obesity","Obesity Type 2 Diabetes Mellitus","MASH",[178,17,179,180],"gastroduodenal liner","wight management","glycemic control","NOT_YET_RECRUITING","2026-02-10",{"date":184,"type":185},"2026-02-18","ACTUAL",{"date":187,"type":167},"2026-03",{"date":189,"type":167},"2028-04",{"name":5,"class":6},8]