Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness (NCT07716384) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
150 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Significant Liver Fibrosis (≥F2)
Timeframe: Baseline (Day 1)
2
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Cirrhosis (F4)
Timeframe: Baseline (Day 1)
Trial details
NCT IDNCT07716384
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University