An observational study in Cardiac Disease, sponsored by UltraSight. Completed at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by UltraSight · Observational
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.
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.
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 99 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →UltraSight is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Up to 100 male and female adults confirmed as eligible according to eligibility criteria.
Exclusion Criteria:
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.)
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: 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)
Time frame: 1 year.
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: 1. Qualitative visual assessment of RV function: (Yes/No) 2. Qualitative visual assessment of left atrium size: (Yes/No) 3. Qualitative visual assessment of Aortic valve structure: (Yes/No) 4. Qualitative visual assessment of Mitral valve structure: (Yes/No) 5. Qualitative visual assessment of Tricuspid valve structure: (Yes/No) 6. Qualitative visual assessment of IVC size: (Yes/No)
Time frame: 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
Time frame: 1 year.
Safety outcome.
Adverse Events.
Time frame: 1 year.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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