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NCT07242404

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

Not yet recruiting Last updated 21 November 2025
What this trial tests

trial in MAFLD in 224 participants. Not yet recruiting.

Timeline
1 December 2025
Primary endpoint
31 May 2026
31 May 2026

Quick facts

Lead sponsorHong You
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment224
Start date1 December 2025
Primary completion31 May 2026
Estimated completion31 May 2026

Conditions studied

Sponsor

Hong You

Who can join

18 and older, any sex, with MAFLD or HEPATITIS B CHRONIC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing