DiagnosisMACH IQNCT06360926
Improvement Image Quality for SuperSonic® MACH Ultrasound System
A study testing SuperSonic® Ultrasound System in people with Diagnosis, run by SuperSonic Imagine at 1 site in France.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnosis
- What is being tested?
- SuperSonic® Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2024to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SuperSonic® Ultrasound System
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperSonic® Ultrasound SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| SuperSonic® Ultrasound System equipped with new software iterations used with a new probe | Experimental | Not described Receives: Device: SuperSonic® Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During ultrasound procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Jul 2024
- Primary completion23 May 2025
- Study completion23 May 2025
Why it stopped: End of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuperSonic Imagine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360926
- Sponsor's protocol ID
- 2024-A00526-41
- Acronym
- MACH IQ
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Image Quality for SuperSonic® MACH Ultrasound System
- ClinicalTrials.gov ID
- NCT06360926
- Acronym / sponsor ID
- MACH IQ / 2024-A00526-41
- Conditions
- Diagnosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of the study
- Enrolment
- 55 participants (actual)
- Lead sponsor
- SuperSonic ImagineIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SuperSonic® Ultrasound System equipped with new software iterations used with a new probe | Experimental | Device: SuperSonic® Ultrasound System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperSonic® Ultrasound SystemSuperSonic® 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 | Device | SuperSonic® Ultrasound System equipped with new software iterations used with a new probe |
Primary outcome
Qualitative assessment of image quality
Time frame: 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
Results and safety
The study was stopped early (reason given: End of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperSonic® Ultrasound System in people with Diagnosis, run by SuperSonic Imagine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of image quality (time frame: During ultrasound procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.