Actively Recruiting
Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease
Led by Hangzhou Tangji Medical Technology Co., Ltd. · Updated on 2024-06-26
10
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.
CONDITIONS
Official Title
Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged between 18 and 65 years old
- Diagnosis of nonalcoholic fatty liver disease
- Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) of 8% or higher
- Body mass index (BMI) of 24 or higher
- Patients who understand the study purpose, voluntarily participate, have signed informed consent, and can comply with all study requirements including follow-up and evaluations
You will not qualify if you...
- History of excessive alcohol consumption (more than 30 g/day for males, more than 20 g/day for females)
- End-stage liver disease such as hepatic cirrhosis or hepatic cancer, or other conditions causing fatty liver
- Inability to complete MR examination
- Use of nonsteroidal anti-inflammatory drugs or corticosteroids in the past month
- Iron deficiency or iron deficiency anemia
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels increased to 8 times upper limit of normal (ULN), and bilirubin increased to 2 times ULN
- Coagulation disorders or bleeding tendency (platelets less than 100 x 10^9/L)
- Duodenal ulcer, previous or current pancreatitis
- History of liver abscess
- History of gallstones (symptomatic or stones larger than 20mm)
- Gastrointestinal hemorrhage or risk of hemorrhage
- Gastrointestinal tract anomalies that could prevent device placement
- History of intestinal obstruction or related disease in the past year
- Drug abuse or uncontrolled psychiatric disorders
- Any contraindication to endoscopy judged by the investigator
- Pregnancy or lactating women
- Participation in other drug or medical device clinical studies
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
Z
Ziru Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here