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RECRUITING
NCT05495139
NA

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

Sponsor: Hangzhou Tangji Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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