Ultrasound Index Fat Fraction | NCT06373796

Studies
Ultrasound Index Fat Fraction

NCT06373796

Sponsor

SuperSonic Imagine

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Steatosis of Liver

Interventions

Echographic scan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2024Actual

Primary Completion Date

Jan 30, 2025Actual

Completion Date

Jan 30, 2025Actual

First Submitted Date

Apr 16, 2024

First Submission Date that Met QC Criteria

Apr 16, 2024

First Posted Date

Apr 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Label	Type	Description	Intervention Names
FAT PLUS	Experimental		Device: Echographic scan

Name	Type	Description	Arm Group Labels	Other Names
Echographic scan	Device	Liver ultrasound exam	FAT PLUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FAT PLUS	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.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Christophe Aubé, MD	University Hospital, Angers	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers		Angers		49000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases