NCT07716384Not yet recruiting
Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
Diagnostic Accuracy of a Wearable Patch-Type Ultrasound Probe for Detecting Liver Fibrosis and Cirrhosis: A Prospective Cross-Sectional Study
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- NCT number
- NCT07716384
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Oct 2026 to the primary completion date, 1 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute hepatitis or acute-on-chronic liver failure at the time of enrollment
- History of liver transplantation
- 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)
Other
- Ascites (may interfere with liver stiffness measurement by either device) Body mass index (BMI) ≥ 35 kg/m² (may reduce measurement reliability of transient elastography)
- Hepatocellular carcinoma or other space-occupying liver lesions
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.