NCT06561529

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: MDCECRO LLC · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibrosis
• Liver

Interventions

Type	Name	Description
DEVICE	Gastric 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.

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-08-20
• Last updated: 2025-05-08

Locations

2 sites across 1 country: Latvia