Non-alcoholic Fatty Liver Disease (NAFLD)NCT07268937
Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2023to 5 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an age > 18 years
Who may be able to join
- age > 18 years,
- ability to hold breath for image acquisition,
- informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia
Pavia, Pavia, 27100
About this study
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.
- Being tested
- CAP (Controlled Attenuation Parameter) module implemented on the Fibroscan machine.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the results relating to the degree of steatosis detected by the various ultrasound devices with the CAP module
Measured: 05 May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start6 Jul 2023
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Poma, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268937
- Sponsor's protocol ID
- p_168
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices
- ClinicalTrials.gov ID
- NCT07268937
- Acronym / sponsor ID
- p_168
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an age > 18 years
Key inclusion criteria (3 listed)
- age > 18 years,
- ability to hold breath for image acquisition,
- informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.