Echocardiographic.
DeviceEchocardiographic test.
NCT Number: NCT05090748
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.
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Notify Me18 year–120 year
All sexes
Observational
Sheba MC, Ramat Gan, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Echocardiographic test.
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:
Time frame: 1 year.
The expert cardiologists will evaluate whether the echo examination performed by novice users has sufficient quality to evaluate the following six (6) anatomic elements:
Time frame: 1 year.
The expert cardiologists will evaluate if each of the following 10 views taken by novice users can be considered of diagnostic quality:
Time frame: 1 year.
Adverse events.
UltraSight
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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