Liver FibrosisNCT07716384
Wearable Patch Ultrasound Probe for Diagnosis of Liver Stiffness
An observational study of Liver Fibrosis and Liver Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Liver Cirrhosis, NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Wearable Patch-Type Ultrasound Probe and Transient Elastography (FibroScan)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Accuracy of a Wearable Patch-Type Ultrasound Probe for Detecting Liver Fibrosis and Cirrhosis: A Prospective Cross-Sectional Study
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.
Read the detailed description
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.
- Conditions
- Liver Fibrosis, Liver Cirrhosis, NAFLD (Nonalcoholic Fatty Liver Disease), HEPATITIS B CHRONIC
- Being tested
- Wearable Patch-Type Ultrasound Probe, Transient Elastography (FibroScan)
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Patch-Type Ultrasound ProbeDevice
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease Patients | Not described Receives: Device: Wearable Patch-Type Ultrasound Probe; Device: Transient Elastography (FibroScan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 1)
Secondary outcomes (9)
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.
Measured: 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
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.
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1)
Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4)
Sensitivity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting cirrhosis (F4), using FibroScan-determined fibrosis stage as the reference standard.
Measured: Baseline (Day 1)
Specificity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4)
Specificity of the wearable patch ultrasound probe, at the optimal cut-off value, for detecting cirrhosis (F4), using FibroScan-determined fibrosis stage as the reference standard.
Measured: Baseline (Day 1)
Positive Predictive Value (PPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
PPV 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.
Measured: Baseline (Day 1)
Negative Predictive Value (NPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
NPV 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.
Measured: Baseline (Day 1)
Correlation and Agreement Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements
Agreement between liver stiffness values obtained from the wearable patch ultrasound probe and FibroScan will be assessed using Pearson correlation coefficient and Bland-Altman analysis to evaluate systematic bias and limits of agreement.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716384
- Sponsor's protocol ID
- XJTUSAH-WB-002
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of a Wearable Patch-Type Ultrasound Probe for Detecting Liver Fibrosis and Cirrhosis: A Prospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07716384
- Acronym / sponsor ID
- XJTUSAH-WB-002
- Conditions
- Liver Fibrosis, Liver Cirrhosis, NAFLD (Nonalcoholic Fatty Liver Disease), HEPATITIS B CHRONIC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease Patients | – | Device: Wearable Patch-Type Ultrasound Probe, Device: Transient Elastography (FibroScan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Patch-Type Ultrasound ProbeAn 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. | Device | Chronic Liver Disease Patients |
| Transient Elastography (FibroScan)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). | Device | Chronic Liver Disease Patients |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Significant Liver Fibrosis (≥F2)
Time frame: Baseline (Day 1)
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.
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Cirrhosis (F4)
Time frame: Baseline (Day 1)
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.
9 secondary outcomes
Correlation and Agreement Between Wearable Patch Ultrasound Probe and Reference Standard Liver Stiffness Measurements
Time frame: 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
Time frame: Baseline (Day 1)
Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Time frame: Baseline (Day 1)
Specificity of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Time frame: Baseline (Day 1)
Sensitivity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4)
Time frame: Baseline (Day 1)
Specificity of the Wearable Patch Ultrasound Probe for Detecting Cirrhosis (F4)
Time frame: Baseline (Day 1)
Positive Predictive Value (PPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Time frame: Baseline (Day 1)
Negative Predictive Value (NPV) of the Wearable Patch Ultrasound Probe for Detecting Significant Liver Fibrosis (≥F2)
Time frame: Baseline (Day 1)
Correlation and Agreement Between Wearable Patch Ultrasound Probe and FibroScan Liver Stiffness Measurements
Time frame: Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Liver Cirrhosis, run by Second Affiliated Hospital of Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUC) for Detecting Significant Liver Fibrosis (≥F2) (time frame: Baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.