Automated Ultrasound Cardiac Guidance Tool

NCT05649826 | Recruiting

• 1 other identifier: 002-30 US
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ultrasound Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Emergency (non-elective) admission within 24 h prior to participating in the study
• Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
• Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
• Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
• Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
• Subjects with BMI above 40.
• Subjects experiencing a known or suspected acute cardiac event.
• Subjects with severe chest wall deformity as per previous medical records and physical examination.
• Subjects who have undergone pneumonectomy.
• 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.).

Sponsors & Collaborators

• UltraSight: lead

Study Sites (1)

Wayne University

Detroit, Michigan, 48201, United States

RECRUITING

Study Officials

• Robert Ehrman, MD

  Wayne University Emergency medicine

  PRINCIPAL INVESTIGATOR

• Noa Avisar, PhD

  UltraSight

  STUDY DIRECTOR

Central Study Contacts

Robert Ehrman, MD

CONTACT

313-5771268; rehrman@med.wayne.edu

Laura Gowland, Sonographer

CONTACT

313-5771268; lgowland@med.wayne.edu

Study Design

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

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: December 14, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (1)