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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Device: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziru Liu; Phone Number: 0571-86702039; Email: lzr@tangjimedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A single arm study, only investigational product; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hangzhou Tangji Medical Technology Co., Ltd.
• Investigators: Principal Investigator: LunGen Lu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HZTJ03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No