Trials / Recruiting
RecruitingNCT06661655
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- E-Scopics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.
Detailed description
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF. The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF. The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE. Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.
Conditions
- Metabolic Syndrome X
- Fatty Liver
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- MASLD
- NASH (Non-Alcoholic Steatohepatitis)
- Steatosis, Liver
- NAFLD
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Liver ultrasound | Hepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis. |
Timeline
- Start date
- 2025-07-24
- Primary completion
- 2026-03-01
- Completion
- 2026-09-01
- First posted
- 2024-10-28
- Last updated
- 2025-08-15
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06661655. Inclusion in this directory is not an endorsement.