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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic. | Device | Echocardiographic test. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome. | Adverse events. | 1 year. |
Inclusion Criteria:
Exclusion Criteria:
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
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.).
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male and female adults confirmed as eligible according to eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Lang, MD | U of Chicago | Principal Investigator |
| Federico Asch, MD | Medstar Health Research Institute | Principal Investigator |
| Praveen Mehrotra, MD | Thomas Jefferson University | Principal Investigator |
| Bijoy Khandheria, MD | Aurora Saint Luke Medical Center | Principal Investigator |
| Robert Klampfner, MD | Sheba Medical Center | Principal Investigator |
| Danny Spigelstein, MD | UltraSight | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637, | United States | ||
| Aurora St. Luke's Medical Center |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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:
| 1 year. |
| Milwaukee |
| Wisconsin |
| 53215, |
| United States |
| Sheba MC | Ramat Gan | Israel |