Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
Recruiting · NCT06661655 · Interventional (participants receive a specific treatment) · Lead sponsor: E-Scopics
View the official record on ClinicalTrials.gov →Interventions studied
Liver ultrasound
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adult patient below 80 yo
- Patients with MASLD/MASH recruited in interventional trials requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients with MASLD/MASH recruited in prospective cohorts requiring MRI PDFF +/- MRE per interventional protocol, OR
- Patients referred to MRI-PDFF or MRE.
- Patients who consented in written to participate in the study
- Patients with ongoing social security coverage
Exclusion criteria
- Patient in their minority (less than 18 yo) or older than 80 yo,
- Patient with active implants,
- Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)
- Patient with a history of decompensated cirrhosis,
- Patient with a history of hepatocellular carcinoma,
- Adult patient under tutorship, or unable to express informed consent,
- Pregnant or breast-feeding
- Person deprived from their liberty
- Patient hospitalized without providing consent or in case of an emergency
- Patient presenting with another know liver disease
Where it is running
3 locations listed.
- University Hospital Angers - Angers, France
- Beaujon University Hospital - Clichy, France
- Pitie Salpetriere University Hospital - Paris, France