Human Factors Study of Ultrasound Navigation Software for... | NCT05660044

Studies
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

NCT05660044

Sponsor

UltraSight

Status

Completed

Last Update Posted

Dec 21, 2022Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Cardiac Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Aug 3, 2022Actual

Completion Date

Aug 3, 2022Actual

First Submitted Date

Dec 5, 2022

First Submission Date that Met QC Criteria

Dec 13, 2022

First Posted Date

Dec 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2022

Last Update Posted Date

Dec 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danny Spiegelstein, MD	UltraSight	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba medical center		Ramat Gan			Israel