About this trial
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 criteria
Qualifiers
Age 18-65 years.
BMI ≥ 30 kg/m².
Historical biochemical tests for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9
Fibroscan, transient elastography ≥8.5 kPa, controlled attenuation parameter ≥280 dB/m
Disqualifiers
None
Trial design
Treatments tested in this trial
- Gastric Bypass Stent System
Treatment groups
Sponsors and collaborators
MDCECRO LLC
Lead sponsor
Hangzhou Tangji Medical Technology Co., Ltd.
Collaborator