[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Trans-Duodenal Concepts GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100625057","multicentric-approval-study-trans-duodenal-barrier-for-typ-2-diabetes-with-obesity-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":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29,30],"Typ 2 Diabetes","Obesity","Obesity Type 2 Diabetes Mellitus","MASH",[32,33,34,35],"gastroduodenal liner","endoscopic implant","wight management","glycemic control","NOT_YET_RECRUITING","2026-02-10",{"date":39,"type":40},"2026-02-18","ACTUAL",{"date":42,"type":21},"2026-03",{"date":44,"type":21},"2028-04",{"name":46,"class":47},"Trans-Duodenal Concepts GmbH","INDUSTRY",8,""]