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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HEPATITIS B CHRONIC; MAFLD

• Study Type: Observational
• Enrollment (Estimated): 224

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic Liver Disease Cohort; Adults with chronic hepatitis B and/or MASH receiving paired liver elastography assessments for agreement analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	At baseline
Agreement Between Supine and Sitting Measurements (Handheld Device)	At baseline

Collaborators and Investigators

• Sponsor: Hong You

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Transient Elastography; Noninvasive Liver Assessment; Agreement Study
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: 2025-P2-511-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No