RecruitingNot ApplicableNCT06561529

The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region

A Prospective, Open-label, Single-arm Clinical Study to Evaluate the Safety and Performance of the Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region

Sponsor

MDCECRO LLC

Enrollment

10 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Fibrosis Liver

Summary

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Gastric Bypass Stent System for people with fibrosis and liver. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGastric Bypass Stent System

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity holds potential as a non-invasive technique for managing hepatic fibrosis. This clinical investigation will be used to evaluate the safety and performance of the investigational device for the intended use.