Trials / Unknown
UnknownNCT05120557
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- E-Scopics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Liver Diseases
- Liver Cirrhosis
- NASH - Nonalcoholic Steatohepatitis
- Non-Alcoholic Fatty Liver Disease
- Fibrosis, Liver
- Steatosis of Liver
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultrasound liver assessment | The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research. |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2021-11-15
- Last updated
- 2022-08-23
Source: ClinicalTrials.gov record NCT05120557. Inclusion in this directory is not an endorsement.