NCT05495139RecruitingNot Applicable
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.
Hangzhou Tangji Medical Technology Co., Ltd.1 site in 1 country10 target enrollmentStarted: December 15, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes of MRI-PDFF
Study Overview
Brief Summary
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
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.
Intervention: Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease (Device)
Outcomes
Primary Outcomes
Changes of MRI-PDFF
Time Frame: 24 weeks after device implantation procedure(Visit 7)
Changes of MRI-PDFF at device retrieval
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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