Efficacy and Safety of the Gastric Bypass Stent System on Body Weight and Metabolic Parameters in Obese Patients

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 11, 2021

Primary Completion Date

October 3, 2022

Study Completion Date

October 3, 2022

Conditions
Obesity
Interventions
DEVICE

the Gastric Bypass Stent System

The Gastric Bypass Stent System is a newly designed endoscopic duodenal-jejunal bypass liner for the treatment of obesity by Hangzhou Tangji Medical Technology Co., Ltd.. It consists of three main parts: a 60-cm polyethylene sleeve fixed into the duodenal bulb by anchors with barbs, a delivery system and a retrieval system. Compared to the Endobarrier, it has several technical adjustments. First, it improved sleeve materials to provide better barrier properties and reduce the breeding of bacteria resulting in hepatic abscess. Second, the barbs on the anchoring system have been modified to reduce duodenal injury. Third, the delivery and retrieval system have been optimized to eliminate the need of fluoroscopic guidance during implantation and explantation.

Trial Locations (1)

100050

Beijing Friendship Hospital, Beijing

All Listed Sponsors
collaborator

Hangzhou Tangji Medical Technology Co., Ltd.

OTHER

lead

Beijing Friendship Hospital

OTHER

NCT05864911 - Efficacy and Safety of the Gastric Bypass Stent System on Body Weight and Metabolic Parameters in Obese Patients | Biotech Hunter | Biotech Hunter