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Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH (POCUS-NASH)

Primary Purpose

Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound liver assessment
Sponsored by
E-Scopics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases focused on measuring Elastography, Ultrasound attenuation, Sound speed, Ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Main arm

    Arm Description

    Main study arm

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    November 3, 2021
    Last Updated
    August 22, 2022
    Sponsor
    E-Scopics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05120557
    Brief Title
    Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
    Acronym
    POCUS-NASH
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    E-Scopics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fibrosis, Liver, Steatosis of Liver
    Keywords
    Elastography, Ultrasound attenuation, Sound speed, Ultrasound

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Main arm
    Arm Type
    Experimental
    Arm Description
    Main study arm
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound liver assessment
    Other Intervention Name(s)
    Elastography, Ultrasound attenuation, Sound speed
    Intervention Description
    The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
    Primary Outcome Measure Information:
    Title
    Elastography diagnostic performance
    Description
    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.
    Time Frame
    At study completion, 1 year
    Title
    Diagnostic performance estimates
    Description
    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
    Time Frame
    At study completion, 1 year
    Secondary Outcome Measure Information:
    Title
    Liver stiffness robustness indicators
    Description
    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
    Time Frame
    At study completion, 1 year
    Title
    Equivalence with other methods
    Description
    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
    Time Frame
    At study completion, 1 year
    Other Pre-specified Outcome Measures:
    Title
    Exploratory outcome 1: Liver steatosis
    Description
    R² correlation coefficient and p-value between ES1 ultrasound attenuation measurements and MRI PDFF Concordance Correlation Coefficients (CCC) and 95% confidence intervals, and Bland-Altman graphs between ultrasound attenuation measurements and MRI PDFF R² correlation coefficient and p-value between ES1 speed of sound measurements and MRI PDFF Concordance Correlation Coefficients (CCC) and 95% confidence intervals, and Bland-Altman graphs between speed of sound measurements and MRI PDFF
    Time Frame
    At study completion, 1 year
    Title
    Exploratory outcome 2: Intra-hepatic inflammation and/or hepatocytes ballooning
    Description
    Correlation coefficients between ES1 parameters or combinations of parameters and histological scoring for lobular inflammation (A0 to A3) and/or ballooning. If relevant, area under the ROC curve for combinations of ES1 parameters or combinations of parameters used as a diagnostic measures of liver inflammation severity using histological scoring for lobular inflammation (A0 to A3) If relevant for given binary diagnostic objectives (detect ≥ A1, ≥ A2, or A3), calculate optimal diagnostic cutoffs and estimate diagnostic performances
    Time Frame
    At study completion, 1 year
    Title
    Exploratory outcome 3: Liver NAS Score
    Description
    Correlation coefficients between ES1 parameters or combinations of parameters and histological NAS score (NAS 0 to NAS 8). If relevant, area under the ROC curve for combinations of ES1 parameters or combinations of parameters used as a diagnostic measure of NAFLD-related activity using the histological NAS score (0 to 8) If relevant, for given binary diagnostic objectives (detect < NAS 3, ≥ NAS 3, ≥ NAS 5), calculate optimal diagnostic cutoffs and estimate diagnostic performances
    Time Frame
    At study completion, 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH

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