Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness

Chronic liver disease, including chronic viral hepatitis, non-alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease, can progress to liver fibrosis and, ultimately, cirrhosis if left undetected and untreated. Accurate and timely assessment of liver fibrosis stage is essential for guiding clinical management, including treatment initiation, monitoring of disease progression, and screening for cirrhosis-related complications such as esophageal varices and hepatocellular carcinoma.

Liver biopsy has traditionally been considered the gold standard for assessing liver fibrosis; however, it is invasive, carries risk of complications, and is subject to sampling variability. Transient elastography (FibroScan) has emerged as a widely validated non-invasive alternative, providing a reliable estimate of liver stiffness that correlates with fibrosis stage. However, FibroScan requires a dedicated, non-portable device and a trained operator, and access may be limited in certain clinical settings, particularly outside of specialized hepatology centers.

Wearable ultrasound technology has advanced substantially in recent years, offering the potential for a simplified, patch-type probe that can be applied directly to the skin over the liver to estimate tissue stiffness. Such a device could potentially lower the technical barrier for liver stiffness assessment and expand access to non-invasive fibrosis screening. However, the diagnostic accuracy of this wearable patch-type ultrasound probe for detecting clinically significant fibrosis and cirrhosis has not yet been established in a clinical population.

This study is a prospective cross-sectional diagnostic accuracy study. Patients with chronic liver disease will be enrolled and will undergo liver stiffness measurement using both the investigational wearable patch-type ultrasound probe and FibroScan (transient elastography) at the same clinical visit. FibroScan results will be used as the reference standard to classify patients according to fibrosis stage, including significant fibrosis (≥F2) and cirrhosis (F4). The diagnostic performance of the wearable patch ultrasound probe will be evaluated by calculating sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC) for each clinically relevant fibrosis threshold, along with the corresponding optimal cut-off values. In addition, the correlation and agreement between liver stiffness values obtained from the wearable patch probe and FibroScan will be assessed using Pearson correlation coefficient and Bland-Altman analysis.

The results of this study are expected to provide preliminary evidence on whether the wearable patch-type ultrasound probe can serve as a reliable, accessible, non-invasive tool for the diagnosis of liver fibrosis and cirrhosis in patients with chronic liver disease.

• Correlation and Agreement Between Wearable Patch Ultrasound Probe and Reference Standard Liver Stiffness Measurements [Срок оценки: At the time of enrollment (single time-point assessment)]
• Correlation Coefficient Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements, Stratified by Fibrosis Severity Subgroup [Срок оценки: Baseline (Day 1)]
• Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) [Срок оценки: Baseline (Day 1)]
• Specificity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) [Срок оценки: Baseline (Day 1)]
• Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4) [Срок оценки: Baseline (Day 1)]
• Specificity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4) [Срок оценки: Baseline (Day 1)]
• Positive Predictive Value (PPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) [Срок оценки: Baseline (Day 1)]
• Negative Predictive Value (NPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2) [Срок оценки: Baseline (Day 1)]
• Correlation and Agreement Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements [Срок оценки: Baseline (Day 1)]