Clinical trial NCT05090748: Study for the Assessment of the Quality of Echocardiographic Clips.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Lead sponsor: UltraSight
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female adults confirmed as eligible according to eligibility criteria.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 and older
2. Subjects willing and able to give written informed consent.

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
6. Subjects with BMI above 40
7. Subjects experiencing a known or suspected acute cardiac event
8. Subjects with severe chest wall deformity as per previous medical records and physical examination
9. Subjects who have undergone pneumonectomy
10. 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.).

Primary outcomes:
measure: Evaluation of the echo examination sufficiency.
timeFrame: 1 year.
Secondary outcomes:
measure: Evaluation of the echo examination quality.
timeFrame: 1 year.
measure: Evaluation of the echo examination diagnostic quality.
timeFrame: 1 year.
Other outcomes:
measure: Safety outcome.
timeFrame: 1 year.
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Ramat Gan
country: Israel
facility: Sheba MC
Study officials:
affiliation: U of Chicago
name: Roberto Lang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Federico Asch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Praveen Mehrotra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Saint Luke Medical Center
name: Bijoy Khandheria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Robert Klampfner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UltraSight
name: Danny Spigelstein, MD
role: STUDY_DIRECTOR
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