Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients with confirmed or suspected chronic liver disease (including chronic viral hepatitis, non-alcoholic fatty liver disease, and alcohol-related liver disease) presenting for routine clinical evaluation, consecutively enrolled to capture a continuous spectrum of liver fibrosis severity ranging from no/mild fibrosis to cirrhosis. All eligible patients will undergo liver stiffness measurement using both the investigational wearable patch-type ultrasound probe and transient elastography (FibroScan) as the reference standard.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Wearable Patch-Type Ultrasound Probe
DeviceAn 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)
DeviceA 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).
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Chronic Liver Disease Patients2 interventions
Trial outcomes
Primary outcomes
1
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Significant Liver Fibrosis (≥F2)
The AUC of the wearable patch ultrasound probe for distinguishing patients with significant fibrosis (≥F2) from those with no/mild fibrosis (F0-F1), using FibroScan-determined fibrosis stage as the reference standard.
Time frame
Baseline (Day 1)2
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Cirrhosis (F4)
The AUC of the wearable patch ultrasound probe for distinguishing patients with cirrhosis (F4) from those without cirrhosis (F0-F3), using FibroScan-determined fibrosis stage as the reference standard.
Time frame
Baseline (Day 1)Secondary outcomes
1
Correlation and Agreement Between Wearable Patch Ultrasound Probe and Reference Standard Liver Stiffness Measurements
Agreement between liver stiffness values obtained from the wearable patch ultrasound probe and the reference standard (FibroScan) will be assessed using Pearson correlation coefficient and Bland-Altman analysis to evaluate systematic bias and limits of agreement across the full range of measured values.
Time frame
At the time of enrollment (single time-point assessment)2
Correlation Coefficient Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements, Stratified by Fibrosis Severity Subgroup
Patients will be stratified into subgroups based on FibroScan-determined fibrosis stage (no/mild fibrosis \[F0-F1\], significant fibrosis \[F2-F3\], and cirrhosis \[F4\]). Within each subgroup, the Pearson correlation coefficient between liver stiffness values (measured in kPa) obtained from the wearable patch ultrasound probe and FibroScan will be calculated to assess whether measurement agreement varies with disease severity.
Time frame
Baseline (Day 1)3
Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Sensitivity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard.
Time frame
Baseline (Day 1)4
Specificity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Specificity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting significant fibrosis (≥F2), using FibroScan-determined fibrosis stage as the reference standard.
Time frame
Baseline (Day 1)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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