Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness

Liver stiffness measurement is a key non-invasive tool for assessing liver fibrosis and cirrhosis in patients with chronic liver disease. Transient elastography (FibroScan) is currently the most widely used non-invasive reference standard, but it requires a dedicated device and trained operator, which may limit its accessibility in some clinical settings. This study aims to evaluate the diagnostic accuracy of a novel wearable patch-type ultrasound probe for detecting significant liver fibrosis and cirrhosis, using FibroScan as the reference standard. Patients with chronic liver disease will undergo simultaneous liver stiffness measurement using both the wearable patch ultrasound probe and FibroScan. The diagnostic performance of the patch probe, including sensitivity, specificity, and area under the receiver operating characteristic curve (AUC), will be evaluated against fibrosis staging determined by FibroScan, along with the correlation and agreement between the two measurement methods.

Inclusion Criteria: * Confirmed or suspected chronic liver disease (including but not limited to chronic viral hepatitis, non-alcoholic fatty liver disease, and alcohol-related liver disease) * Scheduled to undergo, or have recently undergone, transient elastography (FibroScan) as part of routine clinical care * Age ≥ 18 years * Willing and able to provide signed informed consent Exclusion Criteria: * Ascites (may interfere with liver stiffness measurement by either device) Body mass index (BMI) ≥ 35 kg/m² (may reduce measurement reliability of transient elastography) * Acute hepatitis or acute-on-chronic liver failure at the time of enrollment * History of liver transplantation * Hepatocellular carcinoma or other space-occupying liver lesions * Pregnant women * Skin lesions, infection, or scarring at the intended probe application site (right lobe of the liver, intercostal space) * Unable to cooperate with the measurement procedure (e.g., severe cognitive impairment)