Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness

NCT07716384 | Not Yet Recruiting

• 1 other identifier: XJTUSAH-WB-002
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Fibrosis; Liver Cirrhosis; NAFLD (Nonalcoholic Fatty Liver Disease); HEPATITIS B CHRONIC

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Day 1)

• 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.

  Baseline (Day 1)

Secondary Outcomes (9)

• Correlation and Agreement Between Wearable Patch Ultrasound Probe and Reference Standard Liver Stiffness Measurements

  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

  Baseline (Day 1)

• Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)

  Baseline (Day 1)

• Specificity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)

  Baseline (Day 1)

• Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4)

  Baseline (Day 1)

Study Arms (1)

Chronic Liver Disease Patients

Device: Wearable Patch-Type Ultrasound Probe; Device: Transient Elastography (FibroScan)

Interventions

Transient Elastography (FibroScan) DEVICE

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).

Chronic Liver Disease Patients

Wearable Patch-Type Ultrasound Probe DEVICE

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.

Chronic Liver Disease Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07