Clinical trial NCT05495139: Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: Hangzhou Tangji Medical Technology Co., Ltd.
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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;

Primary outcomes:
measure: Changes of MRI-PDFF
timeFrame: 24 weeks after device implantation procedure(Visit 7)
Secondary outcomes:
measure: Changes of MRI-PDFF
timeFrame: 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Changes of liver stiffness measurement (LSM)
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Changes of liver inflammation/injury indicators (ATL, ASL, GGT, ALP, TBil, and DBil)
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Changes of blood glucose indicators (fasting insulin, fasting blood glucose, fasting C-peptide, and insulin resistance [e.g. HOMA-IR])
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: 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)
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Changes of hepatic fibrosis indicators (PIIINP, Fibro Test/Fibro Sure, ELF, and NFS)
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Percent changes of body weight and changes of BMI
timeFrame: 24 weeks after the implantation procedure (Visit 7), and 12 weeks after device retrieval(Visit 8) and 24 weeks after device retrieval(Visit 9)
measure: Histological changes
timeFrame: 24 weeks after the implantation procedure (Visit 7)
measure: Evaluation on the usability of the device
timeFrame: 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)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Lungen Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Baiwen Li
role: PRINCIPAL_INVESTIGATOR
References: