Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

NCT07268937 | Completed

• 1 other identifier: p_168
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module

  05 May 2025

Interventions

CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine. DEVICE

Use of the CAP module implemented on the Fibroscan machine to compare the results of the degree of steatosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an age \> 18 years

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 6, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

IT (1)