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Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07268937
Enrollment
25
Registered
2025-12-08
Start date
2023-07-06
Completion date
2025-05-05
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

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.

Interventions

DEVICECAP (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

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module05 May 2025

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026