Improvement Image Quality for SuperSonic® MACH Ultrasound System

NCT06360926 | Terminated

• 1 other identifier: 2024-A00526-41
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SuperSonic® Ultrasound System equipped with new software iterations used with a new probe

EXPERIMENTAL

Device: SuperSonic® Ultrasound System

Interventions

SuperSonic® Ultrasound System DEVICE

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

SuperSonic® Ultrasound System equipped with new software iterations used with a new probe

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperSonic Imagine: lead

Study Sites (1)

Hôpital Necker-Enfants malades

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 11, 2024
• Study Start: July 15, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)