NCT05660044

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

June 1, 2022

Enrollment Period

14 days

First QC Date

December 5, 2022

Last Update Submit

December 13, 2022

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

  • Usability of UltraSight AI guidance software

    Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction

    10 days

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

28-34 study participants will be recruited to meet at least one of the following professions: * Attending Physicians and/or Medical Residents * Registered Nurses (RNs), Nurse Practitioners (NPs) and Physician Assistants (PAs) * Medical assistants (CMAs)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Danny Spiegelstein, MD

    UltraSight

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 21, 2022

Study Start

July 20, 2022

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

December 21, 2022

Record last verified: 2022-06

Locations

IL(1)