NCT05495139

Gastric Bypass Stent Small-Sample-Size Study For 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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hangzhou Tangji Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the preliminary effectiveness and safety of the Gastric Bypass Stent System in treating nonalcoholic fatty liver disease.

Detailed description

The Gastric Bypass Stent System is intended to be used in Patients with Diagnosis of nonalcoholic fatty liver disease， Proton density fat fraction measured by magnetic resonance imaging (MRI-PDFF) ≥8%. In this pivotal, prospective, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System in Treatment of Patients with Nonalcoholic Fatty Liver Disease

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-15
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2022-08-10
• Last updated: 2024-06-26

Locations

1 site across 1 country: China