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Tangji Gastric Bypass Stent Study for Obesity

NCT05938231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-07-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Tangji Medical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • Shutian Zhang · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-05-03
Completion
2022-10-07

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 NCT05938231 on ClinicalTrials.gov