Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness

Brief Summary

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.

Related Devices