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

NCT06661655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome X
  • Fatty Liver
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • MASLD
  • NASH (Non-Alcoholic Steatohepatitis)
  • Steatosis, Liver
  • NAFLD

Interventions

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.

Sponsors & Collaborators

  • E-Scopics

    lead INDUSTRY

Principal Investigators

  • Claude Cohen-Bacrie · E-Scopics

  • Jerome Boursier, MD, PhD · University Hospital, Angers

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2026-03-01
Completion
2026-09-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661655 on ClinicalTrials.gov