NCT05495139招募中不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes of MRI-PDFF
研究概览
简要总结
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
详细描述
The Gastric Bypass Stent System is intended to be used in Patients with Diagnosis of nonalcoholic fatty liver disease， Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%. In this pivotal, prospective, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（ - ） Males or females with age between 18 and 65 years old;
- •（ - ） Diagnosis of nonalcoholic fatty liver disease;
- •（ - ） Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%;
- •（ - ） BMI≥24;
- •Patients 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.
排除标准
- •（ - ） History of excessive alcohol consumption (alcohol consumption equivalent to ethanol > 30 g/d for males and > 20 g/d for females);
- •（ - ） End-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver;
- •（ - ） Unable to cooperate to complete MR examination;
- •（ - ） Subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month;
- •（ - ） Patients with iron deficiency or iron deficiency anemia;
- •（ - ） ALT or AST increased to 8 × upper limit of normal (ULN), and bilirubin increased to 2×ULN;
- •（ - ） Patients with coagulation disorder or haemorrhagic diathesis (platelets <100×109/L);
- •（ - ） Patients with duodenal ulcer, or previous or existing pancreatitis;
- •（ - ） History of liver abscess;
- •（ - ） History of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm);
- •（ - ） Patients with gastrointestinal hemorrhage or potential hemorrhage;
- •（ - ） Gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract;
- •（ - ） Patients with history of intestinal obstruction or related disease in the past year;
- •（ - ） Drug abusers or patients with uncontrollable psychiatric disorders;
- •（ - ） Patients with any contraindication to endoscopy based on the investigator's judgment;
- •（ - ） Pregnancy or lactating women;
- •（ - ） Patients who are participating in any other drug or medical device clinical study;
- •（ - ） Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;
结局指标
主要结局
Changes of MRI-PDFF
时间窗: 24 weeks after device implantation procedure(Visit 7)
Changes of MRI-PDFF at device retrieval
次要结局
- Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil)(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR])(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Changes of blood lipids indicators, including triglyceride, total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein CIII, and lipoprotein (a)(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Histological changes(24 weeks after the implantation procedure (Visit 7))
- Evaluation on the usability of the device(4 weeks after the implantation procedure (Visit 4) 、12 weeks after the implantation procedure (Visit 5)and 18 weeks after the implantation procedure (Visit 6))
- Changes of MRI-PDFF(12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS)(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Changes of liver stiffness measurement (LSM)(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
- Percent changes of body weight and changes of BMI(24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9))
研究者
研究点 (1)
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