[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Tangji Medical Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100477297","gastric-bypass-stent-small-sample-size-study-for-nonalcoholic-fatty-liver-disease-100477297",false,"NCT05495139","Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease","A Small-Sample-Size Clinical Study to Evaluate the Effectiveness and Safety of the Gastric Bypass Stent System in Treatment of Patients With Nonalcoholic Fatty Liver Disease.","Inclusion Criteria:\n\n（ - ） Males or females with age between 18 and 65 years old;\n\n（ - ） Diagnosis of nonalcoholic fatty liver disease;\n\n（ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;\n\n（ - ） BMI≥24;\n\nPatients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations.\n\nExclusion Criteria:\n\n（ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol \\> 30 g\u002Fd for males and \\> 20 g\u002Fd for females);\n\n（ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;\n\n（ - ） Unable to cooperate to complete MR examination;\n\n（ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;\n\n（ - ） Patients with iron deficiency or iron deficiency anemia;\n\n（ - ） ALT or AST increased to 8 × upper limit of normal (ULN), and bilirubin increased to 2×ULN;\n\n（ - ） Patients with coagulation disorder or haemorrhagic diathesis (platelets \\\u003C100×109\u002FL);\n\n（ - ） Patients with duodenal ulcer, or previous or existing pancreatitis;\n\n（ - ） History of liver abscess;\n\n（ - ） History of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm);\n\n（ - ） Patients with gastrointestinal hemorrhage or potential hemorrhage;\n\n（ - ） Gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract;\n\n（ - ） Patients with history of intestinal obstruction or related disease in the past year;\n\n（ - ） Drug abusers or patients with uncontrollable psychiatric disorders;\n\n（ - ） Patients with any contraindication to endoscopy based on the investigator's judgment;\n\n（ - ） Pregnancy or lactating women;\n\n（ - ） Patients who are participating in any other drug or medical device clinical study;\n\n（ - ） Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;","ALL","18 Years","65 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.",[27],"Nonalcoholic Fatty Liver Disease","RECRUITING","2024-06-25",{"date":31,"type":32},"2024-06-26","ACTUAL",{"date":34,"type":32},"2022-12-15",{"date":36,"type":21},"2026-06-30",{"name":38,"class":39},"Hangzhou Tangji Medical Technology Co., Ltd.","OTHER",""]