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Tangji EU Gastric Bypass Stent Study for Obesity

Obesity Clinical Trial

Official title:
A Prospective, Open-label, Multicenter, Single-arm Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Weight Loss Treatment for Obesity

Clinical Trial Summary

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the European Union (EU) and United Kingdom (UK).

Clinical Trial Description

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this pivotal, prospective, multicenter, single-arm clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the European Union (EU) and United Kingdom (UK). This clinical investigation will be used as an EU/UK bridging study and, with the ongoing clinical investigation in China (Protocol number: HZTG01), will be used to evaluate the safety and performance of the investigational device for the intended use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05249608
Study type Interventional
Source Hangzhou Tangji Medical Technology Co., Ltd.
Contact
Status Not yet recruiting
Phase N/A
Start date June 1, 2023
Completion date June 1, 2025
View Details
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