Cardiac DiseaseNCT05660044
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging
An observational study of Cardiac Disease, run by UltraSight at 1 site in Israel.
Trial summary
The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jul 2022to 3 Aug 2022
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 28-34 study participants will be recruited to meet at least one of the following professions: * Attending Physicians and/or Medical Residents * Registered Nurses (RNs), Nurse Practitioners (NPs) and Physician Assistants (PAs) * Medical assistants (CMAs)
Who may be able to join
- Age 18 and older
- Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
- Have the capacity to understand study risks and consent to be in the study
- Be available and willing to participate in the study
- Not be employed by the Sponsor or another medical device or pharmaceutical company
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging
The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.
Read the detailed description
Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.
- Conditions
- Cardiac Disease
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of UltraSight AI guidance software
Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start20 Jul 2022
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- UltraSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danny Spiegelstein, MD, Study director, UltraSight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660044
- Sponsor's protocol ID
- USEG 301
- Status last verified
- Jun 2022
- First submitted
- 5 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging
- ClinicalTrials.gov ID
- NCT05660044
- Acronym / sponsor ID
- USEG 301
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- UltraSightIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 21 Dec 2022 (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 Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.
Detailed description
Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 28-34 study participants will be recruited to meet at least one of the following professions: * Attending Physicians and/or Medical Residents * Registered Nurses (RNs), Nurse Practitioners (NPs) and Physician Assistants (PAs) * Medical assistants (CMAs)
Key inclusion criteria (5 listed)
- Age 18 and older
- Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
- Have the capacity to understand study risks and consent to be in the study
- Be available and willing to participate in the study
- Not be employed by the Sponsor or another medical device or pharmaceutical company
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of UltraSight AI guidance software
Time frame: 10 days
Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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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.
Danny Spiegelstein, MD study director
UltraSight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by UltraSight at 1 site in Israel.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 21 Dec 2022. 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 Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability of UltraSight AI guidance software (time frame: 10 days). 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 21 Dec 2022.