NCT07242404Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 224 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 May 2026
- Lead sponsor
- Hong You
- Diseases
- Hepatitis B
- NCT number
- NCT07242404
What you commit to
- Study type: Observational
- Planned participants: 224
- From 1 Dec 2025 to the primary completion date, 31 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic/metabolic liver disease).
- Co-infection with HIV.
- History of liver transplantation or TIPS.
Lab values
- Total bilirubin \> 51 μmol/L.
- ALT \> 5 × upper normal limit.
Other
- Evidence of decompensated cirrhosis.
- Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions.
- Pregnancy.
- Congestive hepatopathy.
- Unhealed wounds in the right upper abdomen.
- Inability to maintain the required sitting position.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.