Chronic Liver DiseaseUS-REFERRALNCT06387745
Referral of Patients to Hepatology With Hepatoscope
A study testing Hepatoscope in people with Chronic Liver Disease, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Hepatoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2025to Dec 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any of the following
- Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
- Type 2 diabetes
- Elements of metabolic syndrome
- Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation
Who cannot join
- Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
- Pregnant and breastfeeding women,
- People deprived of their freedom rights.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, 2650
Luisa Vonghia, MD - PhD, 003238213323, studies.hepatologie@uza.be
About this study
Official title: Use of Ultrasound Tools to Refer Patients at Risk of Chronic Liver Disease to the Hepatology Consultation (US-REFERRAL)
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.
Read the detailed description
Chronic liver diseases (CLD) remain asymptomatic for a long time, until they become decompensated (cirrhosis) or lead to liver cancer. CLD all have a very similar natural history: over several years, or even tens of years, liver fibrosis develops progressively, which leads to cirrhosis and the related risks of complications of cirrhosis, including portal hypertension, liver failure, of even liver cancer.
In the absence of complications, liver fibrosis and cirrhosis remain completely symptomatic. For this reason, several methods for the non-invasive assessment of liver fibrosis have been developed over the last 20 years, with the objective to screen for liver fibrosis in it early stage so as to manage the patient and potentially prevent to development of complications. There are 2 groups of such noninvasive methods: blood-based tests and methods that measure the liver stiffness, which is directly correlated to liver fibrosis severity.
There are simple blood tests such as the FIB-4 and others can be more complex like FibroTest.
The FIB-4 test, which takes into account 4 parameters easily available (age, platelets, and 2 liver enzymes, AST and ALT), is very useful in the general population because of its high negative predictive value. However, it is mainly used for the diagnosis of liver fibrosis in the context of chronic viral hepatitis.
The measurement of liver stiffness is currently available on a hepatology-dedicated device, the FibroScan, or on high-end ultrasound imaging systems that are available in radiology centers. This measurement of liver stiffness has demonstrated excellent performances for the diagnosis of cirrhosis and a good performance for the assessment of liver fibrosis severity at earlier stages. However, in clinical practice, this method is not widely available nor accessible (cost of equipment of limited to radiology centers).
For the diagnosis of liver steatosis (excess of fat accumulation in the liver), which can also lead to liver fibrosis, cirrhosis and its complications, the Gold Standard exam that can quantify the extent of fat in the liver is Magnetic Resonance Imaging derived Proton Density Fat Fraction (MRI PDFF), but its use in routine is extremely limited due to the lack of MRI equipment, their cost, and the cost of MRI exams. Liver steatosis can be assessed with ultrasound imaging systems (in radiology) and also with FibroScan, although the interpretation of exam results remains variable.
In primary care, in diabetology-endocrinology and in the hepatology practice, it is now known that the screening of chronic liver diseases at their early stages is of paramount importance for a proper management of patients. New simple, available and affordable tools are urgently needed to cover the territory and assess patients at risk where they are, at the point of care, during consultations.
This clinical trial will assess the performance of an ultra-portable, point-of-care ultrasound device for the assessment of liver fibrosis and steatosis in the primary care setting, to optimize referral of patients to the tertiary hepatology consultation for further specialist investigation.
- Conditions
- Chronic Liver Disease
- Being tested
- Hepatoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatoscopeDevice
The Hepatoscope is a non-invasive external ultrasound imaging device, intended for general purpose pulse echo ultrasound imaging, and soft tissue elasticity imaging of the human body. In addition, the Hepatoscope provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | Single arm study protocol Receives: Device: Hepatoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value for significant fibrosis
Estimation of Positive Predictive Value in percentage with 95% confidence interval for estimation of significant fibrosis.
Measured: at study completion: 12 months
Secondary outcomes (3)
Correlation of stiffness measurements
Liver stiffness measurements performed with the device subject of the research and competitor device will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
Measured: at study completion: 12 months
Concordance of stiffness measurements
Liver stiffness measurements performed with the device subject of the research and competitor device will be compared by analysis of concordance. The analysis outcome will be the Concordance Correlation Coefficients (CCC) and 95% confidence intervals.
Measured: at study completion: 12 months
Diagnostic performance of liver stiffness measurements
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to referral outcome. Diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values.
Measured: at study completion: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start22 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- E-Scopics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387745
- Sponsor's protocol ID
- US-REFERRAL
- Acronym
- US-REFERRAL
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2024
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound Tools to Refer Patients at Risk of Chronic Liver Disease to the Hepatology Consultation (US-REFERRAL)
- ClinicalTrials.gov ID
- NCT06387745
- Acronym / sponsor ID
- US-REFERRAL / US-REFERRAL
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- E-Scopics
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2024 (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.
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.
Detailed description
Chronic liver diseases (CLD) remain asymptomatic for a long time, until they become decompensated (cirrhosis) or lead to liver cancer. CLD all have a very similar natural history: over several years, or even tens of years, liver fibrosis develops progressively, which leads to cirrhosis and the related risks of complications of cirrhosis, including portal hypertension, liver failure, of even liver cancer.
In the absence of complications, liver fibrosis and cirrhosis remain completely symptomatic. For this reason, several methods for the non-invasive assessment of liver fibrosis have been developed over the last 20 years, with the objective to screen for liver fibrosis in it early stage so as to manage the patient and potentially prevent to development of complications. There are 2 groups of such noninvasive methods: blood-based tests and methods that measure the liver stiffness, which is directly correlated to liver fibrosis severity.
There are simple blood tests such as the FIB-4 and others can be more complex like FibroTest.
The FIB-4 test, which takes into account 4 parameters easily available (age, platelets, and 2 liver enzymes, AST and ALT), is very useful in the general population because of its high negative predictive value. However, it is mainly used for the diagnosis of liver fibrosis in the context of chronic viral hepatitis.
The measurement of liver stiffness is currently available on a hepatology-dedicated device, the FibroScan, or on high-end ultrasound imaging systems that are available in radiology centers. This measurement of liver stiffness has demonstrated excellent performances for the diagnosis of cirrhosis and a good performance for the assessment of liver fibrosis severity at earlier stages. However, in clinical practice, this method is not widely available nor accessible (cost of equipment of limited to radiology centers).
For the diagnosis of liver steatosis (excess of fat accumulation in the liver), which can also lead to liver fibrosis, cirrhosis and its complications, the Gold Standard exam that can quantify the extent of fat in the liver is Magnetic Resonance Imaging derived Proton Density Fat Fraction (MRI PDFF), but its use in routine is extremely limited due to the lack of MRI equipment, their cost, and the cost of MRI exams. Liver steatosis can be assessed with ultrasound imaging systems (in radiology) and also with FibroScan, although the interpretation of exam results remains variable.
In primary care, in diabetology-endocrinology and in the hepatology practice, it is now known that the screening of chronic liver diseases at their early stages is of paramount importance for a proper management of patients. New simple, available and affordable tools are urgently needed to cover the territory and assess patients at risk where they are, at the point of care, during consultations.
This clinical trial will assess the performance of an ultra-portable, point-of-care ultrasound device for the assessment of liver fibrosis and steatosis in the primary care setting, to optimize referral of patients to the tertiary hepatology consultation for further specialist investigation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Device: HepatoscopeSingle arm study protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with any of the following
- Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation
Key exclusion criteria (4 listed)
- Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
- Pregnant and breastfeeding women,
- People deprived of their freedom rights.
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 |
|---|---|---|
| HepatoscopeThe Hepatoscope is a non-invasive external ultrasound imaging device, intended for general purpose pulse echo ultrasound imaging, and soft tissue elasticity imaging of the human body. In addition, the Hepatoscope provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body. | Device | Investigational Arm |
Primary outcome
Positive Predictive Value for significant fibrosis
Time frame: at study completion: 12 months
Estimation of Positive Predictive Value in percentage with 95% confidence interval for estimation of significant fibrosis.
3 secondary outcomes
Correlation of stiffness measurements
Time frame: at study completion: 12 months
Concordance of stiffness measurements
Time frame: at study completion: 12 months
Diagnostic performance of liver stiffness measurements
Time frame: at study completion: 12 months
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 8 May 2026.
- Individual participant dataSharing planned: No
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Liver Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatoscope in people with Chronic Liver Disease, run by University Hospital, Antwerp at 1 site in Belgium.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value for significant fibrosis (time frame: at study completion: 12 months). 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 8 May 2026.