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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Bordeaux University Hospital
Pessac, France
Correlation of biomarkers to existing biomarker references
Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
Time frame: At study completion, 1 year
Diagnostic performance of biomarkers in research
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers. Conventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.
Time frame: At study completion, 1 year
Repeatability intraclass correlation coefficients (ICC)
Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.
Time frame: At study completion, 1 year
Reproducibility intraclass correlation coefficients (ICC)
Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.
Time frame: At study completion, 1 year
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