Optimization of an Automated Ultrasound Cardiac Guidance Tool

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04981444

Enrollment

Registered

2021-07-29

Start date

2021-07-22

Completion date

2022-09-23

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Therapy

Brief summary

Open-label, single-arm, prospective study. Subjects will undergo one session of 2D Transthoracic Echocardiogram (2D-TTE) ultrasound. The ultrasound will be performed by a trained sonographer.

Detailed description

The study will use a commercially available handheld imaging device (Philips Lumify transducer). Primary Objective: To acquire images of multiple transducer position, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe positions.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

1. Age 18 years and above. 2. Patients able to understand, read and sign the informed consent 3. Patient willing to answer a short questionnaire

Exclusion criteria

1. Pregnancy(females of childbearing potential will be tested with a urine pregnancy test prior to their inclusion in the study) 2. Not willing or not able to sign an inform consent 3. Physical limitation to maneuvering the probe on the body 4. Unable to lie flat for study 5. Patients experiencing a known or suspected acute cardiac event 6. Patients with severe chest wall abnormalities 7. Patients who have undergone pneumonectomy 8. Patients whose anatomy does not lend itself to echocardiography

Design outcomes

Primary

Measure	Time frame	Description
ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.	1 year	To acquire images from different transducer positions, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe. This study is designed to capture data for the training of the UltraSight Guidance software AI models. The obtained data will not be anlyzed for statistical purposes but will only be used for the algorithm development based on the technician movements recording, with no reference to images quality or medical utilization.

Countries

United States

Outcome results