Diagnosis Clinical Trial
— MACH IQOfficial title:
Improvement Image Quality for SuperSonic® MACH Ultrasound System
Verified date | April 2024 |
Source | SuperSonic Imagine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SuperSonic Imagine |
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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