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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05120557
Study type Interventional
Source E-Scopics
Contact
Status Not yet recruiting
Phase N/A
Start date January 2022
Completion date January 2023

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