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Gastric Bypass Stent Small-Sample-Size Study For Nonalcoholic Fatty Liver Disease
Sponsor: Hangzhou Tangji Medical Technology Co., Ltd.
Summary
Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating 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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2022-12-15
Completion Date
2026-06-30
Last Updated
2024-06-26
Healthy Volunteers
No
Conditions
Interventions
Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease
This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 6-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 12 months.
Locations (1)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China