Optimization of an Automated Ultrasound Cardiac Guidance Tool

Completed

• Conditions: Ultrasound Therapy

• Registration Number: NCT04981444
• Lead Sponsor: UltraSight

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.

Study Timeline

• Study First Submitted: 2021-07-04
• Study Start: 2021-07-22
• Study First Submitted QC: 2021-07-24
• Study First Posted: 2021-07-29
• Primary Completion: 2021-09-20
• Status Verified: 2022-07
• Study Completion: 2022-09-23
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States