Study of Hepatoscope Ultrasound Device for Non-Invasive Liver Fat Assessment in Adults with Metabolic Liver Diseases

What this Trial Is About

Researchers are evaluating an ultraportable ultrasound device called Hepatoscope for non-invasive assessment of liver fat hepatic steatosis in patients with metabolic dysfunction-associated liver diseases MASLD and MASH. The study compares Hepatoscopes measurements to current diagnostic methods like MRI-PDFF, aiming to assess how well the device measures liver fat and stiffness. This research is sponsored by E-Scopics and focuses on patients with fatty liver conditions related to metabolic syndrome. Participants will undergo an ultrasound exam using the Hepatoscope device to collect quantitative data related to liver steatosis severity. The device measures ultrasound attenuation, backscattering coefficient, and sound speed. The study compares these ultrasound parameters to liver fat fraction measured by MRI-PDFF and also evaluates comparisons with FibroScan and magnetic resonance elastography MRE for liver stiffness. Some patients may also have liver biopsy results for further comparison. During the study, participants will receive the Hepatoscope ultrasound exam and have their measurements compared with MRI-PDFF within six months of enrollment. Other evaluations include FibroScan and MRE comparisons. The study involves written consent, ongoing social security coverage, and monitoring for safety and accuracy. The total participation timeline and follow-up procedures align with the imaging and clinical assessments conducted within this period.

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients