Cardiac DiseaseNCT05067803
Study for the Assessment of USEG Software.
An observational study of Cardiac Disease, run by UltraSight at 1 site in Israel.
Trial summary
The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- How many people
- 99 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Dec 2021to 23 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 100 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 (WOCBP* 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 echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, 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
1 site in 1 country.
About this study
Official title: Pilot Study for the Assessment of the Quality of Echocardiography Exam When Obtained by Novice Users While Using the USEG Software.
The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.).
The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study.
- Images can be acquired manually by a novice user.
- Each novice user will have a training course of 8 hours, before the study commences.
Read the detailed description
Study Design:
This pilot study is a single center, multi-reader multi-case study, primarily designed to obtain the quality of the echocardiography exam, obtained by novice users when using the USEG software.
Eligible subject will undergo the examination twice on a single study visit : once by one of novice users when using the USEG software and once by one of the expert sonographers without the aid of the software.
Each novice user will perform the examination on approximately 30 subjects (depending on the number of novice user, with the aim that the number of examinations by each novice will be the same).
The assignment of the novice user and expert sonographer to subjects and their order within a subject will be based upon their availability once the subject's is enrolled. In case of more than 1 available novice, the exam will be assigned to the novice with the least exams performed so far.
At least 10 subjects will be enrolled from each of the following three BMI groups= < 25; =25 to <30; => 30.
Study Procedures:
After an informed consent is obtained, screening was completed and eligibility has been confirmed, each subject will undergo the examination twice on the day of visit (Day 1): once by a novice user and once by an expert sonographer.
In case of any administrative delay, the investigator may address the issue with the sponsor, and upon approval, the second examination may be postponed in up to 96 hours.
The novice user will obtain at least 10 clips using the UltraSight guidance software for 10 pre-defined views from each patient, and an expert sonographer will obtain 10 clips for the same at least 10 views without the aid of the UltraSight software.
The order in which the novice user and expert sonographer performs the examination per patient will be based on their availability once the subject's is enrolled. In case of more than 1 available novice, the exam will be assigned to the novice with the least exams performed so far.
Adverse events will be monitored throughout the visit.
- 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.
To assess the quality of clips obtained by novice users when using the USEG software.
The expert cardiologists will evaluate whether the echo examination 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)
Sufficient quality assessment for six (6) anatomic elements.
The expert cardiologists will evaluate whether the echo examination 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.
Diagnostic quality assessment.
The expert cardiologists will evaluate if each of the following 10 views 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)f
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 posted5 Oct 2021
- Study start24 Dec 2021
- Primary completion23 Jan 2022
- Study completion23 Jan 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- UltraSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Klempfner, MD, Principal investigator, Sheba MCDanny Spiegelstein, MD, Study director, UltraSight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067803
- Sponsor's protocol ID
- USEG-101
- Status last verified
- Feb 2022
- First submitted
- 23 Sep 2021
- Last updated
- 11 Apr 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Assessment of the Quality of Echocardiography Exam When Obtained by Novice Users While Using the USEG Software.
- ClinicalTrials.gov ID
- NCT05067803
- Acronym / sponsor ID
- USEG-101
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- UltraSightIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 23 Jan 2022 (actual)
- Study completion
- 23 Jan 2022 (actual)
- First posted
- 5 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.
The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.).
The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study.
- Images can be acquired manually by a novice user.
- Each novice user will have a training course of 8 hours, before the study commences.
Detailed description
Study Design:
This pilot study is a single center, multi-reader multi-case study, primarily designed to obtain the quality of the echocardiography exam, obtained by novice users when using the USEG software.
Eligible subject will undergo the examination twice on a single study visit : once by one of novice users when using the USEG software and once by one of the expert sonographers without the aid of the software.
Each novice user will perform the examination on approximately 30 subjects (depending on the number of novice user, with the aim that the number of examinations by each novice will be the same).
The assignment of the novice user and expert sonographer to subjects and their order within a subject will be based upon their availability once the subject's is enrolled. In case of more than 1 available novice, the exam will be assigned to the novice with the least exams performed so far.
At least 10 subjects will be enrolled from each of the following three BMI groups= < 25; =25 to <30; => 30.
Study Procedures:
After an informed consent is obtained, screening was completed and eligibility has been confirmed, each subject will undergo the examination twice on the day of visit (Day 1): once by a novice user and once by an expert sonographer.
In case of any administrative delay, the investigator may address the issue with the sponsor, and upon approval, the second examination may be postponed in up to 96 hours.
The novice user will obtain at least 10 clips using the UltraSight guidance software for 10 pre-defined views from each patient, and an expert sonographer will obtain 10 clips for the same at least 10 views without the aid of the UltraSight software.
The order in which the novice user and expert sonographer performs the examination per patient will be based on their availability once the subject's is enrolled. In case of more than 1 available novice, the exam will be assigned to the novice with the least exams performed so far.
Adverse events will be monitored throughout the visit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 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 (WOCBP* 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.
Primary outcome
To assess the quality of clips obtained by novice users when using the USEG software.
Time frame: 1 year.
The expert cardiologists will evaluate whether the echo examination 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
Sufficient quality assessment for six (6) anatomic elements.
Time frame: 1 year.
Diagnostic quality assessment.
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 11 Apr 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.
Robert Klempfner, MD principal investigator
Sheba MC
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 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 11 Apr 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?
To assess the quality of clips obtained by novice users when using the USEG software. (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 11 Apr 2022.