MedTrace Logo

Tangji EU Gastric Bypass Stent Study for Obesity

NCT05249608 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-15

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 European Union (EU) and United Kingdom (UK).

Conditions

Interventions

DEVICE

A prospective, open-label, multicenter, single-arm clinical study to evaluate the safety and performance of the Gastric Bypass Stent System as a weight loss treatment for obesity

This study includes 3 phases; screening period, procedural period, and a follow-up period. Following a 2-week screening period, subjects will be treated with the Gastric Bypass Stent System implanted under gastroscopy (Visit 2; Day 0). Following a 3-month treatment period, the device is removed, and subjects are followed for 6 months. In total subject participation will last for approximately 9 months.

Sponsors & Collaborators

  • Hangzhou Tangji Medical Technology Co., Ltd.

    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
2023-06-01
Primary Completion
2025-02-02
Completion
2025-06-01

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 NCT05249608 on ClinicalTrials.gov