Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients

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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Key information

Conditions

MAFLD Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes HEPATITIS B CHRONIC Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
History of liver transplantation or TIPS.
Pregnancy.
Congestive hepatopathy.
Unhealed wounds in the right upper abdomen.
Inability to maintain the required sitting position.

Treatment and study plan

Primary outcomes

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)

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

Sponsors and collaborators

Lead sponsor

Hong You

Other

Registry information

Official study title

Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 21, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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