Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.

Detailed Description
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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

Official Title
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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.

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: （ - ） 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. Exclusion Criteria: （ - ） 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single arm study, only investigational product<br>To evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease. | Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of MRI-PDFF | Changes of MRI-PDFF at device retrieval | 24 weeks after device implantation procedure(Visit 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of MRI-PDFF | Changes of MRI-PDFF at 12 and 24 weeks after device retrieval | 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9) | 
| Changes of liver stiffness measurement (LSM) | Changes of liver stiffness measurement (LSM) at device retrieval, and 12 and 24 weeks after device retrieval | 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 inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil) | Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil) at device retrieval, and 12 and 24 weeks after device retrieval | 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]) | Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR]) at device retrieval, and 12 and 24 weeks after device retrieval | 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) | 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), at device retrieval, and 12 and 24 weeks after device retrieval | 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 hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS) | Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS) at device retrieval, and 12 and 24 weeks after device retrieval | 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 | Percent changes of body weight and changes of BMI at device retrieval and 12 and 24 weeks after device retrieval | 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 | Histological changes at device retrieval | 24 weeks after the implantation procedure (Visit 7) | 
| Evaluation on the usability of the device | Use abdominal X-ray evaluate Device implantation status | 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) |