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Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation — DIACEPA  

Liver Cirrhosis Clinical Trial

Official title:
Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie

Clinical Trial Summary

Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

Clinical Trial Description

The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment. Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment. Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04782050
Study type Interventional
Source E-Scopics
Contact
Status Completed
Phase N/A
Start date September 15, 2021
Completion date August 29, 2022
View Details
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