Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06661655

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

Led by E-Scopics · Updated on 2025-08-15

120

Participants Needed

3

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient below 80 years old
  • Patients with MASLD or MASH recruited in interventional trials requiring MRI PDFF with or without MRE per protocol
  • Patients with MASLD or MASH recruited in prospective cohorts requiring MRI PDFF with or without MRE per protocol
  • Patients referred for MRI-PDFF or MRE
  • Patients who have provided written consent to participate
  • Patients with ongoing social security coverage
Not Eligible

You will not qualify if you...

  • Patients younger than 18 or older than 80 years old
  • Patients with active implants
  • Patients with wounds in the right upper abdominal area where the Hepatoscope exam would be performed
  • Patients with a history of decompensated cirrhosis
  • Patients with a history of hepatocellular carcinoma
  • Adults under tutorship or unable to provide informed consent
  • Pregnant or breastfeeding patients
  • Persons deprived of their liberty
  • Patients hospitalized without consent or in an emergency situation
  • Patients with other known liver diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University Hospital Angers

Angers, France, 49933

Actively Recruiting

2

Beaujon University Hospital

Clichy, France, 92110

Actively Recruiting

3

Pitie Salpetriere University Hospital

Paris, France, 75013

Not Yet Recruiting

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Research Team

J

Jerome Boursier, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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