[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477297":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":34,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hangzhou Tangji Medical Technology Co., Ltd.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single arm study, only investigational product","EXPERIMENTAL","To evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.",[13],"Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease","This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 6-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 12 months.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Lungen Lu","Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Baiwen Li",[29],{"name":30,"role":31,"phone":32,"phoneExt":20,"email":33},"Ziru Liu","CONTACT","0571-86702039","lzr@tangjimedical.com",[35],{"facility":24,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Shanghai","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":23,"role":31,"phone":20,"phoneExt":20,"email":20},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"NA","Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.",[68],"Nonalcoholic Fatty Liver Disease","2024-06-25",{"date":71,"type":72},"2024-06-26","ACTUAL",{"date":74,"type":72},"2022-12-15",{"date":76,"type":62},"2026-06-30",{"name":5,"class":6},1]