Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments: Device: CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine.

Study type: Observational

Funder types: Other

Identifiers

NCT07268937

p_168

Details and patient eligibility

About

Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease, with an estimated prevalence of 5-30% in the general population and 55-80% in patients with type 2 diabetes.

Methods for the quantitative and non-invasive assessment of liver fat content have recently been implemented on ultrasound devices, based on the estimation of the ultrasound beam attenuation coefficient and backscattering. These methods are CE marked and already commercially available.

The aim of the study is to compare the results of the degree of steatosis detected by different ultrasound devices with the degree of steatosis of the CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18 years,
• ability to hold breath for image acquisition,
• informed consent

Exclusion criteria

• withdrawal of informed consent,
• any condition which, in the clinical judgement of the investigator, will make further participation in the study unacceptable for that individual patient