Using a gastric bypass stent to treat 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.

This study tests if a special stent used in gastric bypass surgery can help people with nonalcoholic fatty liver disease reduce liver fat and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hangzhou Tangji Medical Technology Co., Ltd. (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05495139 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Gastric Bypass Stent System in patients diagnosed with nonalcoholic fatty liver disease. It is a pivotal, prospective, single-arm investigation that aims to demonstrate the performance of the stent system in reducing liver fat content, as measured by proton density fat fraction through MRI. Participants will be monitored for safety and efficacy throughout the study period. The trial focuses on individuals with a specific fat fraction threshold and a body mass index above a certain level.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 65 with a diagnosis of nonalcoholic fatty liver disease and a proton density fat fraction of 8% or higher.

Not a fit: Patients with end-stage liver disease, significant alcohol consumption history, or other conditions leading to fatty liver may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from nonalcoholic fatty liver disease.

How similar studies have performed: While there is limited data on the specific use of gastric bypass stents for this condition, similar interventions have shown promise in managing liver-related diseases.

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;

Where this trial is running

Shanghai

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Lungen Lu — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ziru Liu

Conditions Nonalcoholic Fatty Liver Disease