Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module
Time Frame: 05 May 2025
Secondary Outcomes
No secondary outcomes reported
Investigators
Gianluigi Poma
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia