NCT05249608

Tangji EU Gastric Bypass Stent Study for Obesity

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hangzhou Tangji Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	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	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 3-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 9 months.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-02-02
• Completion: 2025-06-01
• First posted: 2022-02-21
• Last updated: 2023-03-15