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Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
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.
Official title: Diagnostic Accuracy of a Wearable Patch-Type Ultrasound Probe for Detecting Liver Fibrosis and Cirrhosis: A Prospective Cross-Sectional Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-10-01
Completion Date
2030-10-01
Last Updated
2026-07-21
Healthy Volunteers
Not specified
Interventions
Wearable Patch-Type Ultrasound Probe
An investigational patch-type ultrasound probe applied to the skin over the liver to non-invasively estimate liver tissue stiffness. Measurement results will be compared against the reference standard to evaluate diagnostic accuracy for detecting significant fibrosis and cirrhosis.
Transient Elastography (FibroScan)
A validated, widely used non-invasive reference standard device for measuring liver stiffness, used to classify patients according to fibrosis stage (e.g., significant fibrosis ≥F2, cirrhosis F4).