Optimization of an Automated Ultrasound Cardiac Guidance Tool

NCT04981444 | Completed

• 1 other identifier: 002-20
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy

Outcome Measures

Primary Outcomes (1)

• ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.

  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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 75 cardiac patients will be enrolled in this study.

You may qualify if:

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

You may not qualify if:

• Not willing or not able to sign an inform consent
• Physical limitation to maneuvering the probe on the body
• 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 whose anatomy does not lend itself to echocardiography

Sponsors & Collaborators

• UltraSight: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Praveen Mehrotra, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 29, 2021
• Study Start: July 22, 2021
• Primary Completion: September 20, 2021
• Study Completion: September 23, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)