Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2022-08-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18 and older
* Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
* Have the capacity to understand study risks and consent to be in the study
* Be available and willing to participate in the study
* Not be employed by the Sponsor or another medical device or pharmaceutical company

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danny Spiegelstein, MD

Role: STUDY_DIRECTOR

UltraSight

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheba medical center

Ramat Gan, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USEG 301

Identifier Type: -

Identifier Source: org_study_id