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

Launched by HANGZHOU TANGJI MEDICAL TECHNOLOGY CO., LTD. · Aug 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option called the Gastric Bypass Stent System to help people with nonalcoholic fatty liver disease (NAFLD). NAFLD is a condition where fat builds up in the liver without alcohol being the cause, which can lead to serious health issues. The trial aims to find out if this stent system is safe and effective for treating this disease. They are currently recruiting participants between the ages of 18 and 65 who have been diagnosed with NAFLD and have a specific level of fat in their liver, as measured by an MRI scan.

To join the study, participants need to meet certain criteria, such as having a body mass index (BMI) of 24 or higher and understanding the study’s goals. However, individuals with a history of heavy drinking, severe liver disease, or certain other medical conditions won't be eligible to participate. Those who do join can expect to receive the treatment and will need to attend follow-up appointments for evaluations. This study is an important step toward finding new ways to help manage nonalcoholic fatty liver disease and improve patients' health.

Gender

ALL

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;