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

NCT ID: NCT04782050

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-08-29

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study arm

Group Type: EXPERIMENTAL

Ultrasound liver assessment

Intervention Type: DEVICE

The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Interventions

Ultrasound liver assessment

The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.

Intervention Type: DEVICE

Other Intervention Names

Elastography; Ultrasound attenuation; Sound speed

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

E-Scopics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor de Lédinghen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Bordeaux University Hospital

Pessac, , France

Countries

France

Other Identifiers

2021-A00612-39

Identifier Type: OTHER

Identifier Source: secondary_id

21.01563.000015

Identifier Type: OTHER

Identifier Source: secondary_id

ES201

Identifier Type: -

Identifier Source: org_study_id