MedTrace Logo

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

NCT05864911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-05-18

No results posted yet for this study

Summary

In this study, the investigators use a novel endoscopic duodenal-jejunal bypass liner-the Gastric Bypass Stent System (Hangzhou Tangji Medical Technology Co., Ltd., China) for the treatment of obesity. The aim of this study is to evaluate the efficacy and safety of this new device on weight loss and obesity-associated metabolic parameters.

Conditions

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.

Sponsors & Collaborators

  • Hangzhou Tangji Medical Technology Co., Ltd.

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2022-10-03
Completion
2022-10-03

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864911 on ClinicalTrials.gov