Tangji BL-RD08-040 Gastric Bypass Stent System
Research type
Research Study
Full title
A prospective, open-label, multicenter, single-arm clinical study to\nevaluate the safety and performance of the Gastric Bypass Stent\nSystem as a weight loss treatment for obesity
IRAS ID
309742
Contact name
John Wong
Contact email
Sponsor organisation
Hangzhou Tangji Medical Technology Co., Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This research study is designed to evaluate the safety and performance (how well it works) of the Gastric Bypass Stent System. The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity. The device works by lining a section of the small intestines and prevents the absorption of digested food. It is inserted (and removed) via the mouth, through the stomach and to the small intestine where it is fixed in place. This concept is similar to that of a traditional gastric bypass but does not involve invasive surgery and is reversible (i.e., the device is removed from the small intestines). \nThe investigational device comprises of the “Gastric Bypass Stent” – the part of the device that is implanted into your small intestine to prevent the absorption of digested food, and components that are involved in the implantation and removal of the device. The main material of the Gastric Bypass Stent is polyethylene (a lightweight plastic). The investigational device has been designed in line with the physiological structure of the human body and should not cause serious damage to the digestive tract.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0144
Date of REC Opinion
3 Aug 2022
REC opinion
Further Information Favourable Opinion