Health TrialsbyHealthPanel

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

ConditionsMAFLDHEPATITIS B CHRONIC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHong You

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

224 Participants
are grouped into 1 trial group
Group A: Chronic Liver Disease Cohort

Trial outcomes

Primary outcomes

1

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

1

ICC for LSM and UAP in the Supine Position

Time frame
At baseline
2

Categorical Agreement in Fibrosis Staging and Steatosis Grading

Time frame
At baseline
3

Agreement Between Devices in the Sitting Position

Time frame
At baseline
4

Agreement Between Supine and Sitting Measurements (Handheld Device)

Time frame
At baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong You

Lead sponsor

Beijing Friendship Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: