Bordeaux University Hospital
Pessac, 33600, France
NCT Number: NCT04782050
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).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Pessac, 33600, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Other names: Elastography, Ultrasound attenuation, Sound speed
Time frame: At study completion, 1 year
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
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 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 will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.
E-Scopics
Industry
Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
Acronym: DIACEPA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06138821
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial DetailsNCT03743272
Autoimmune Diseases, Autoimmune Hepatitis
Leiden, Netherlands
View Trial DetailsNCT03646292
Diabetes Mellitus, Diabetes Mellitus, Type 2
Seoul, South Korea
View Trial DetailsNCT05499585
Digestive System Diseases, Fatty Liver
La Jolla, California, United States
View Trial Details