MAFLDNCT07242404
Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients
An observational study of MAFLD and HEPATITIS B CHRONIC, run by Hong You.
Trial summary
This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MAFLD, HEPATITIS B CHRONIC
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults with chronic liver disease, including chronic hepatitis B, compensated HBV-related cirrhosis, and metabolic dysfunction-associated fatty liver disease (MAFLD), who undergo paired liver elastography measurements using two devices.
Who may be able to join
- Adults aged 18 years or older.
- Diagnosed with one of the following:
- Chronic hepatitis B or compensated HBV-related cirrhosis (based on the 2022 Chinese CHB guidelines), or
- Metabolic dysfunction-associated fatty liver disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), or fibrosis/cirrhosis due to MAFLD (based on the 2024 MAFLD guidelines).
- Willing and able to provide written informed consent.
Who cannot join
- Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic/metabolic liver disease).
- Evidence of decompensated cirrhosis.
- Total bilirubin > 51 μmol/L.
- ALT > 5 × upper normal limit.
- Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions.
- Co-infection with HIV.
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- History of liver transplantation or TIPS.
- Pregnancy.
- Congestive hepatopathy.
- Unhealed wounds in the right upper abdomen.
- Inability to maintain the required sitting position.
About this study
Official title: Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease
This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position.
All participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions.
This study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.
- Conditions
- MAFLD, HEPATITIS B CHRONIC
- Keywords
- Transient Elastography, Noninvasive Liver Assessment, Agreement Study
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease Cohort | Adults with chronic hepatitis B and/or MASH receiving paired liver elastography assessments for agreement analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position
Measured: At the time of liver elastography assessment (baseline)
Secondary outcomes (4)
ICC for LSM and UAP in the Supine Position
Measured: At baseline
Categorical Agreement in Fibrosis Staging and Steatosis Grading
Measured: At baseline
Agreement Between Devices in the Sitting Position
Measured: At baseline
Agreement Between Supine and Sitting Measurements (Handheld Device)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies 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
- Cross-sectional
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong You
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong You, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242404
- Sponsor's protocol ID
- 2025-P2-511-01
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT07242404
- Acronym / sponsor ID
- 2025-P2-511-01
- Conditions
- MAFLD, HEPATITIS B CHRONIC
- Keywords
- Transient Elastography, Noninvasive Liver Assessment, Agreement Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Hong YouUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Nov 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.
This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position.
All participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions.
This study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease Cohort | – | –Adults with chronic hepatitis B and/or MASH receiving paired liver elastography assessments for agreement analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic liver disease, including chronic hepatitis B, compensated HBV-related cirrhosis, and metabolic dysfunction-associated fatty liver disease (MAFLD), who undergo paired liver elastography measurements using two devices.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosed with one of the following:
- Willing and able to provide written informed consent.
Key exclusion criteria (11 listed)
- Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic/metabolic liver disease).
- Evidence of decompensated cirrhosis.
- Total bilirubin > 51 μmol/L.
- ALT > 5 × upper normal limit.
- Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position
Time frame: At the time of liver elastography assessment (baseline)
4 secondary outcomes
ICC for LSM and UAP in the Supine Position
Time frame: At baseline
Categorical Agreement in Fibrosis Staging and Steatosis Grading
Time frame: At baseline
Agreement Between Devices in the Sitting Position
Time frame: At baseline
Agreement Between Supine and Sitting Measurements (Handheld Device)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of MAFLD and HEPATITIS B CHRONIC, run by Hong You.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position (time frame: At the time of liver elastography assessment (baseline)). 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 21 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.