Point-of-Care Echocardiography With Assistance Technology

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

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2019-05-23

Brief Summary

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

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SHAPE:SeeingtheHeartwithAIPoweredEcho

NCT03705650

Cardiac Disease

COMPLETED NA

Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function

NCT05506059

Stroke Volume Cardiovascular Diseases

COMPLETED NA

Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis

NCT06717373

Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease

RECRUITING NA

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

NCT06392555

Congenital Heart Disease

COMPLETED

Impact of Simulator-based Training in Transoesophageal Echocardiography

NCT02537639

Imaging of Heart Disease

COMPLETED

Detailed Description

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

To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

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.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients scheduled for an echocardiogram

Patients ≥18 years scheduled for an echocardiographic examination. This is a non-randomized, un-blinded, study in patients with an indication for an echocardiographic examination. Enrolled patients will be stratified into two groups based on known cardiac abnormalities to ensure a sufficient number of patients with cardiac abnormalities and into 3 strata of BMI: normal, overweight and obese.

Group Type EXPERIMENTAL

Diagnostic Test: Limited Echocardiogram

Intervention Type DIAGNOSTIC_TEST

STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diagnostic Test: Limited Echocardiogram

STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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

Inclusion Criteria

* Patients scheduled for an echocardiographic examination
* Patients ≥18 years old

Exclusion Criteria

* Unable to lie flat for study
* Patients experiencing a known or suspected acute cardiac event
* Patients with severe chest wall abnormalities
* Patients who have undergone pneumonectomy
* Patients unwilling or unable to give written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes