Clinical trial NCT05120557: Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: E-Scopics
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Elastography diagnostic performance
timeFrame: At study completion, 1 year
measure: Diagnostic performance estimates
timeFrame: At study completion, 1 year
Secondary outcomes:
measure: Liver stiffness robustness indicators
timeFrame: At study completion, 1 year
measure: Equivalence with other methods
timeFrame: At study completion, 1 year
Other outcomes:
measure: Exploratory outcome 1: Liver steatosis
timeFrame: At study completion, 1 year
measure: Exploratory outcome 2: Intra-hepatic inflammation and/or hepatocytes ballooning
timeFrame: At study completion, 1 year
measure: Exploratory outcome 3: Liver NAS Score
timeFrame: At study completion, 1 year
Locations:
Study officials:
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