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).
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.
| Condition | liver cirrhosis, LIVER DISEASE, hepatic pathology, Liver Disorders, Hepatic Fibrosis, Cirrhosis, Nonalcoholic Steatohepatitis (NASH), NAFLD, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver Disease, hepatic disease, hepatopathy, liver diseases, non-alcoholic fatty liver, hepatic cirrhosis, hepatic diseases, Liver Disease |
|---|---|
| Treatment | Ultrasound liver assessment |
| Clinical Study Identifier | NCT04782050 |
| Sponsor | E-Scopics |
| Last Modified on | 2 February 2023 |
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