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

NCT ID: NCT07242404

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-05-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic Liver Disease Cohort

Adults with chronic hepatitis B and/or MASH receiving paired liver elastography assessments for agreement analysis.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong You

OTHER

Sponsor Role: lead

Responsible Party

Hong You

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2025-P2-511-01

Identifier Type: -

Identifier Source: org_study_id