Ultrasound Index Fat Fraction

NCT ID: NCT06373796

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2025-01-30

Brief Summary

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The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.

Detailed Description

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Conditions

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Steatosis of Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FAT PLUS

Group Type EXPERIMENTAL

Echographic scan

Intervention Type DEVICE

Liver ultrasound exam

Interventions

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Echographic scan

Liver ultrasound exam

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is ≥ 18 years old.
* Subject is able to understand and sign the Informed Consent Form.
* Subject is able to stand and walk independently.
* Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites.
* Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination
* Subject is affiliated to National Social Insurance or a Health Insurance Regimen

Exclusion Criteria

* Subject is unable or unwilling to adhere to Study procedures
* Subject is unable to understand the Informed Consent
* Subject is unable to express its consent
* Subject is under legal protection
* Subject is deprived of liberty by judicial or administrative decision
* Subject undergoes psychiatric treatment under constraint
* Subject is pregnant or breastfeeding
* Subject has latex allergy
* Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SuperSonic Imagine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Aubé, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU Angers

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2024-A00523-44

Identifier Type: -

Identifier Source: org_study_id

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