Clinical trial NCT04782050: Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Official title: Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Liver Cirrhosis
Non-Alcoholic Fatty Liver Disease
Keywords: Elastography
Attenuation
Sound speed
Ultrasound
Lead sponsor: E-Scopics
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Bordeaux
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).
* Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights
* Patient who is registered to the French social security program

Exclusion Criteria:

* Adult patients under guardianship
* Adult patients not being under guardianship, unable to express consent for participation
* Pregnant women
* Breastfeeding women
* Patients under deprivation of liberty
* In-hospital patients not having given their consent to participate, or admitted in emergency
* Patients admitted in social and care centers for other reasons than those of the research
* Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.

Primary outcomes:
measure: Correlation of biomarkers to existing biomarker references
timeFrame: At study completion, 1 year
measure: Diagnostic performance of biomarkers in research
timeFrame: At study completion, 1 year
Secondary outcomes:
measure: Repeatability intraclass correlation coefficients (ICC)
timeFrame: At study completion, 1 year
measure: Reproducibility intraclass correlation coefficients (ICC)
timeFrame: At study completion, 1 year
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Victor de Lédinghen, MD
role: PRINCIPAL_INVESTIGATOR
References: