NCT04782050

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: E-Scopics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Diseases
• Liver Cirrhosis
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DEVICE	Ultrasound liver assessment	The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-08-29
• Completion: 2022-08-29
• First posted: 2021-03-04
• Last updated: 2023-04-25

Locations

1 site across 1 country: France