Automated Ultrasound Cardiac Guidance Tool

Optimization of an Ultrasound Cardiac Guidance Tool

This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

Study Overview

• Status: Recruiting
• Conditions: Ultrasound Imaging

Detailed Description

The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Robert Ehrman, MD; Phone Number: 313-5771268; Email: rehrman@med.wayne.edu
• Study Contact Backup: Name: Laura Gowland, Sonographer; Phone Number: 313-5771268; Email: lgowland@med.wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne University
      • Principal Investigator: Robert Ehrman, MD
      • Contact: Laura Gowland, sonographer; Phone Number: 313-577-1268; Email: lgowland@med.wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 118 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 200 subjects will be enrolled in this study, at least 35% females and 35% males.

Description

Inclusion Criteria:

1. Males and females, aged 18 years and older
2. Subject willing and able to give written informed consent

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
6. Subjects with BMI above 40.
7. Subjects experiencing a known or suspected acute cardiac event.
8. Subjects with severe chest wall deformity as per previous medical records and physical examination.
9. Subjects who have undergone pneumonectomy.
10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of transthoracic echocardiography media from up to 200 subjects	Several echocardiography views will be acquired from the participants, with in several acoustic windows and views	up to 5 year

Collaborators and Investigators

• Sponsor: UltraSight
• Investigators: Principal Investigator: Robert Ehrman, MD, Wayne University Emergency medicine; Study Director: Noa Avisar, PhD, UltraSight

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): May 1, 2027
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 002-30 US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No