Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

NCT ID: NCT07268937

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-06

Study Completion Date

2025-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Gianluigi Poma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Pavia, Pavia, Italy

Site Status

Countries

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Italy

Other Identifiers

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p_168

Identifier Type: -

Identifier Source: org_study_id

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