RecruitingNot ApplicableNCT06661655

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


Sponsor

E-Scopics

Enrollment

120 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

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Interventions

DEVICELiver 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.


Locations(3)

University Hospital Angers

Angers, France

Beaujon University Hospital

Clichy, France

Pitie Salpetriere University Hospital

Paris, France

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NCT06661655


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