Fatty Liver DiseaseMASLDNCT06720766
Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
An observational study of Fatty Liver Disease, run by The Third People's Hospital of Chengdu at 1 site in China.
Trial summary
The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver Disease
- What is being tested?
- FibbroScan and biopsy
- How many people
- 565 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 31 Jul 2026
- How long will I take part?
- 1 Month
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.
Who may be able to join
- Patients aged 18 years or older who provided written informed consent
- Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
- Patients who schedule to undergo FibroScan examination
Who cannot join
- Patients with ascites or pregnant women
- Patients with any active implantable medical device (such as a pacemaker or defibrillator)
- Patients who have undergone liver transplantation
- Patients with cardiac failure and/or significant valvular disease
- Patients with haemochromatosis
- Patients who have refused to undergo LB or blood tests
- Patients with a confirmed diagnosis of active malignancy, or other terminal disease
- Patients participating in another clinical trial within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.
The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.
- Conditions
- Fatty Liver Disease
- Being tested
- FibbroScan and biopsy
- 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.
FibbroScan and biopsyDiagnostic test
In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis
Measured: Through study completion, an average of 1 year
Cut-off values
Optimal thresholds for application on people with obesity
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start24 Oct 2023
- Primary completion30 Sep 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- 565 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720766
- Sponsor's protocol ID
- 2023-S-177
- Other IDs
- CSY-YNXM-2023-001
- Acronym
- MASLD
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2024
- Last updated
- 1 Oct 2026
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
- ClinicalTrials.gov ID
- NCT06720766
- Acronym / sponsor ID
- MASLD / 2023-S-177
- Conditions
- Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 Dec 2024 (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.
The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.
The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.
Key inclusion criteria (3 listed)
- Patients aged 18 years or older who provided written informed consent
- Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
- Patients who schedule to undergo FibroScan examination
Key exclusion criteria (8 listed)
- Patients with ascites or pregnant women
- Patients with any active implantable medical device (such as a pacemaker or defibrillator)
- Patients who have undergone liver transplantation
- Patients with cardiac failure and/or significant valvular disease
- Patients with haemochromatosis
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 |
|---|---|---|
| FibbroScan and biopsyIn individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination. | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: Through study completion, an average of 1 year
Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis
Cut-off values
Time frame: Through study completion, an average of 1 year
Optimal thresholds for application on people with obesity
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 1 Oct 2026.
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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 Fatty Liver Disease, run by The Third People's Hospital of Chengdu at 1 site in China.
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 8 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 1 Oct 2026. 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 China. 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?
Diagnostic accuracy (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 1 Oct 2026.