NCT07268937

Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
DEVICE	CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine.	Use of the CAP module implemented on the Fibroscan machine to compare the results of the degree of steatosis

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

1 site across 1 country: Italy