NCT05938231

Tangji Gastric Bypass Stent Study for Obesity

A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Weight Loss Treatment for Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• 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 China.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Gastric Bypass Stent System	Subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy. Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months.
BEHAVIORAL	Dietary Intervention	The patients in the trial group or in the control group,have 9-month dietary intervention in the syudy period.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-05-03
• Completion: 2022-10-07
• First posted: 2023-07-10
• Last updated: 2023-07-10

Locations

7 sites across 1 country: China