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NCT06360926 Clinical Trial

Improvement Image Quality for SuperSonic® MACH Ultrasound System

Diagnosis Clinical Trial

— MACH IQ  

Official title:
Improvement Image Quality for SuperSonic® MACH Ultrasound System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06360926
Other study ID # 2024-A00526-41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information
Verified date April 2024
Source SuperSonic Imagine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
SuperSonic Imagine

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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