Diagnosis
Conditions
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).
Interventions
DEVICESuperSonic® 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
Sponsors
SuperSonic Imagine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment of image quality | During ultrasound procedure | 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 |
Countries
France
Outcome results
None listed