Improvement Image Quality for SuperSonic® MACH Ultrasound System (MACH IQ)

The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe).

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnosis
• Intervention / Treatment: Device: SuperSonic® Ultrasound System

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject is ≥ 18 years old and is able to understand and sign the informed consent form.
• Subject is a minor < 18 years old and the legal representative has signed the informed consent form.
• Subject is scheduled for at least one or more routine ultrasounds.
• 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 or his/her legal representative if a minor is unable to express or understand informed consent.
• Subject is under legal protection
• Subject is deprived of liberty by judicial or administrative decision
• Subject undergoes psychiatric treatment under constraint
• Subject is admitted to a health or social establishment for purposes other than research
• Subject has latex allergy.
• Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SuperSonic® Ultrasound System equipped with new software iterations used with a new probe	Device: SuperSonic® Ultrasound System; SuperSonic® Ultrasound System equipped with new software iterations used with a new probe and CE marked probes. The new software and probe are the new study investigational device not CE marked

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of image quality	Following the two ultrasound procedures, the radiologist will rate the image quality produced by the Study Device, compared to that produced by the SOC ultrasound. A score from 1 to 5 (1: Not acceptable; 2: Acceptable; 3: Fair; 4: Good; 5: Excellent) for each of the characteristics of the image: General Aesthetics; Spatial Resolution; Contrast Resolution; Temporal Resolution; Penetration and Sensitivity	During ultrasound procedure

Collaborators and Investigators

• Sponsor: SuperSonic Imagine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A00526-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No