Liver DiseasesPOCUS-NASHNCT05120557
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
A study testing Ultrasound liver assessment in people with Liver Diseases and Liver Cirrhosis, run by E-Scopics.
Trial summary
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Ultrasound liver assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Any of the following criteria:
- Patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a VCTE exam, with or without a blood test, a MRI/MRE exam, a liver biopsy,
- Patients screened for fibrotic NASH in the context of NASH pharmaceutical trials, for which a data sharing agreement has been signed between E-Scopics and the pharmaceutical trial promoter,
- Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
- European patients covered by a social security program
Who cannot join
- Patients under 18 years of age or over 80 years of age,
- Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- Patients presenting wounds at the location where the ES1 probe shall be placed on patients' skin,
- Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures,
- Pregnant and breastfeeding women,
- People deprived of their freedom rights
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- People who have been hospitalized without giving informed consent or under emergency situation,
- People admitted in a social or sanitary institution for other reasons than the Clinical Investigation,
- Patients included in another research study that could interfere with the present Clinical Investigation.
About this study
Official title: Evaluation of Diagnostic Performances of a New Point-of-care Ultrasound System for the Detection of Fibrotic NASH and the Assessment of Liver Disease Severity in Patients With Known or Suspected Chronic Liver Disease
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.
Read the detailed description
This is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in Europe and the USA.
The target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in NASH pharmaceutical trials.
After being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. The system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis.
The study will also assess the repeatability, reproducibility and robustness of quantitative parameters. Collected data will also enable exploring ultrasound-based liver tissue characterization correlated to NASH-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fibrosis, Liver, Steatosis of Liver
- Being tested
- Ultrasound liver assessment
- Keywords
- Elastography, Ultrasound attenuation, Sound speed, Ultrasound
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound liver assessmentDevice
Also called Elastography, Ultrasound attenuation, Sound speed
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | Main study arm Receives: Device: Ultrasound liver assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography diagnostic performance
Differences between areas under ROC curves for the ES1 liver stiffness measurement, used as a diagnostic measure of liver fibrosis severity, and other methods, in NASH patients.
Measured: At study completion, 1 year
Diagnostic performance estimates
Estimates of diagnostic performances at a defined cutoff, for binary diagnostic objectives (detect ≥ F2, ≥ F3, or F4):
- Sensitivity, specificity, and diagnostic accuracy
- Positive and negative predictive values
Measured: At study completion, 1 year
Secondary outcomes (2)
Liver stiffness robustness indicators
- Dispersion and standard deviation of measurements
- Intra-class Correlation Coefficients (ICC) and 95% confidence intervals for intra-operator repeatability
- Intra-class Correlation Coefficients (ICC) and 95% confidence intervals for inter-operator reproducibility
- Intra-subject variance
- Intra-operator variance
- Standard error on measurements
Measured: At study completion, 1 year
Equivalence with other methods
- R² correlation coefficient and p-value between ES1 and VCTE liver stiffness measurements
- R² correlation coefficient and p-value between ES1 and MRE liver stiffness measurements
- Average of quadratic errors between 2 equipment
- Concordance Correlation Coefficients (CCC) and 95% confidence intervals
Measured: At study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-Scopics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120557
- Sponsor's protocol ID
- ES211
- Acronym
- POCUS-NASH
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performances of a New Point-of-care Ultrasound System for the Detection of Fibrotic NASH and the Assessment of Liver Disease Severity in Patients With Known or Suspected Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05120557
- Acronym / sponsor ID
- POCUS-NASH / ES211
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fibrosis, Liver, Steatosis of Liver
- Keywords
- Elastography, Ultrasound attenuation, Sound speed, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- E-ScopicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Nov 2021 (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.
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other non-invasive tests.
Detailed description
This is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in Europe and the USA.
The target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in NASH pharmaceutical trials.
After being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. The system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis.
The study will also assess the repeatability, reproducibility and robustness of quantitative parameters. Collected data will also enable exploring ultrasound-based liver tissue characterization correlated to NASH-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
| Arm | Type | Receives |
|---|---|---|
| Main arm | Experimental | Device: Ultrasound liver assessmentMain study arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any of the following criteria:
- Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation,
- European patients covered by a social security program
Key exclusion criteria (9 listed)
- Patients under 18 years of age or over 80 years of age,
- Patients with active implants such as pacemakers, defibrillators, pumps, etc.
- Patients presenting wounds at the location where the ES1 probe shall be placed on patients' skin,
- Adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures,
- Pregnant and breastfeeding 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 |
|---|---|---|
| Ultrasound liver assessmentAlso: Elastography, Ultrasound attenuation, Sound speedThe intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research. | Device | Main arm |
Primary outcome
Elastography diagnostic performance
Time frame: At study completion, 1 year
Differences between areas under ROC curves for the ES1 liver stiffness measurement, used as a diagnostic measure of liver fibrosis severity, and other methods, in NASH patients.
Diagnostic performance estimates
Time frame: At study completion, 1 year
Estimates of diagnostic performances at a defined cutoff, for binary diagnostic objectives (detect ≥ F2, ≥ F3, or F4): 1. Sensitivity, specificity, and diagnostic accuracy 2. Positive and negative predictive values
2 secondary outcomes
Liver stiffness robustness indicators
Time frame: At study completion, 1 year
Equivalence with other methods
Time frame: At study completion, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound liver assessment in people with Liver Diseases and Liver Cirrhosis, run by E-Scopics.
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 9 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastography diagnostic performance (time frame: At study completion, 1 year). 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 23 Aug 2022.