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

E-Scopics

Status

Unknown

Conditions

Steatosis of Liver

Fibrosis, Liver

Liver Cirrhosis

NASH - Nonalcoholic Steatohepatitis

Non-Alcoholic Fatty Liver Disease

Liver Diseases

Treatments

Device: Ultrasound liver assessment

Study type

Interventional

Funder types

Industry

Identifiers

NCT05120557

ES211

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.