Cardiac DiseaseNCT05090748
Study for the Assessment of the Quality of Echocardiographic Clips.
An observational study of Cardiac Disease, run by UltraSight at 3 sites in 2 countries.
Trial summary
This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Echocardiographic.
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 May 2022to 31 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: male and female adults confirmed as eligible according to eligibility criteria.
Who may be able to join
- Age 18 and older
- Subjects willing and able to give written informed consent.
Who cannot join
- Emergency (non-elective) admission within 24 h prior to participating in the study
- Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
- Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- Subjects who currently participate a clinical trial, involving interventional cardiac devices.
- Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
- Subjects with BMI above 40
Show all 11Show fewer
- Subjects experiencing a known or suspected acute cardiac event
- Subjects with severe chest wall deformity as per previous medical records and physical examination
- Subjects who have undergone pneumonectomy
- Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
- A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Chicago Medicine
Chicago, Illinois, 60637,
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215,
About this study
Official title: A Pivotal Study for the Assessment of the Quality of Echocardiographic Clips When Obtained by Novice Users While Using the UltraSight Echocardiography Guidance (USEG) Software.
This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.
Read the detailed description
This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users.
During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software.
Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations.
- Conditions
- Cardiac Disease
- Being tested
- Echocardiographic.
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic.Device
Echocardiographic test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the echo examination sufficiency.
The expert cardiologists will evaluate whether the echo examination quality obtained by novice users has sufficient to evaluate each of the primary endpoints:
- Sufficient quality to assess Left Ventricular (LV) size: (YES/NO)
- Sufficient quality to assess LV function: (Yes/No)
- Sufficient quality to assess Right Ventricular size: (Yes/No)
- Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)
Measured: 1 year.
Secondary outcomes (2)
Evaluation of the echo examination quality.
The expert cardiologists will evaluate whether the echo examination performed by novice users has sufficient quality to evaluate the following six (6) anatomic elements:
- Qualitative visual assessment of RV function: (Yes/No)
- Qualitative visual assessment of left atrium size: (Yes/No)
- Qualitative visual assessment of Aortic valve structure: (Yes/No)
- Qualitative visual assessment of Mitral valve structure: (Yes/No)
- Qualitative visual assessment of Tricuspid valve structure: (Yes/No)
- Qualitative visual assessment of IVC size: (Yes/No)
Measured: 1 year.
Evaluation of the echo examination diagnostic quality.
The expert cardiologists will evaluate if each of the following 10 views taken by novice users can be considered of diagnostic quality:
- Apical 4 chamber
- Apical 2 chamber
- Apical 3 chamber
- Apical 5 chamber
- Para Sternal Long Axis
- Para Sternal short axis - Aortic Valve (AV)
- Para Sternal short axis - Mitral Valve (MV)
- Para Sternal short axis - Papillary Muscle (PM)
- Sub Costal - 4 chamber
- Sub Costal - Inferior Vena Cava (IVC) In order to assess intra-cardiologist variability, a repeated assessment of the expert cardiologist analysis will be done in 10% of the exams.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start15 May 2022
- Primary completion5 Aug 2022
- Study completion31 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- UltraSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberto Lang, MD, Principal investigator, U of ChicagoFederico Asch, MD, Principal investigator, Medstar Health Research InstitutePraveen Mehrotra, MD, Principal investigator, Thomas Jefferson UniversityBijoy Khandheria, MD, Principal investigator, Aurora Saint Luke Medical CenterRobert Klampfner, MD, Principal investigator, Sheba Medical CenterDanny Spigelstein, MD, Study director, UltraSight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090748
- Sponsor's protocol ID
- USEG- 201
- Status last verified
- Jan 2022
- First submitted
- 11 Oct 2021
- Last updated
- 7 Dec 2022
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study for the Assessment of the Quality of Echocardiographic Clips When Obtained by Novice Users While Using the UltraSight Echocardiography Guidance (USEG) Software.
- ClinicalTrials.gov ID
- NCT05090748
- Acronym / sponsor ID
- USEG- 201
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- UltraSightIndustry (pharma, biotech, devices)
- Study start
- 15 May 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 25 Oct 2021 (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.
This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.
Detailed description
This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users.
During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software.
Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- male and female adults confirmed as eligible according to eligibility criteria.
Key inclusion criteria (2 listed)
- Age 18 and older
- Subjects willing and able to give written informed consent.
Key exclusion criteria (11 listed)
- Emergency (non-elective) admission within 24 h prior to participating in the study
- Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
- Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- Subjects who currently participate a clinical trial, involving interventional cardiac devices.
- Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
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 |
|---|---|---|
| Echocardiographic.Echocardiographic test. | Device | – |
Primary outcome
Evaluation of the echo examination sufficiency.
Time frame: 1 year.
The expert cardiologists will evaluate whether the echo examination quality obtained by novice users has sufficient to evaluate each of the primary endpoints: 1. Sufficient quality to assess Left Ventricular (LV) size: (YES/NO) 2. Sufficient quality to assess LV function: (Yes/No) 3. Sufficient quality to assess Right Ventricular size: (Yes/No) 4. Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)
2 secondary outcomes
Evaluation of the echo examination quality.
Time frame: 1 year.
Evaluation of the echo examination diagnostic quality.
Time frame: 1 year.
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 7 Dec 2022.
- 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.
Roberto Lang, MD principal investigator
U of Chicago
Federico Asch, MD principal investigator
Medstar Health Research Institute
Praveen Mehrotra, MD principal investigator
Thomas Jefferson University
3 sites in 2 countries: 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 3 sites in 2 countries.
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 2 inclusion and 11 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 7 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 3 sites in United States, 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?
Evaluation of the echo examination sufficiency. (time frame: 1 year.). 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 7 Dec 2022.