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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Liver Disease Cohort | Adults with chronic hepatitis B and/or MASH receiving paired liver elastography assessments for agreement analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between the Handheld Elastography Device and iLivTouch for Liver LSM in the Supine Position | At the time of liver elastography assessment (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| ICC for LSM and UAP in the Supine Position | At baseline | |
| Categorical Agreement in Fibrosis Staging and Steatosis Grading | At baseline | |
| Agreement Between Devices in the Sitting Position |
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Inclusion Criteria:
Adults aged 18 years or older.
Diagnosed with one of the following:
Willing and able to provide written informed consent.
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| At baseline |
| Agreement Between Supine and Sitting Measurements (Handheld Device) | At baseline |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |