NCT07242404

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 224 (estimated)
• Sponsor: Hong You · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-11-21
• Last updated: 2025-11-21