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RecruitingNCT05649826Updated May 21, 2024

Automated Ultrasound Cardiac Guidance Tool

An observational study in Ultrasound Imaging, sponsored by UltraSight. Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by UltraSight · Observational

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 120 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Ultrasound Imaging
03

In context

Lead sponsor

UltraSight is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.).
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: up to 5 year

07

Study locations

1 of 1 sites recruiting
  • Wayne University
    Detroit, Michigan 48201, United States
    • Laura Gowland, sonographer · Contact · lgowland@med.wayne.edu · 313-577-1268
    • Robert Ehrman, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05649826
Lead sponsor
UltraSight
Responsible party
Sponsor
First posted
Dec 14, 2022
Start date
Feb 1, 2023
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
May 21, 2024

Study contacts

Robert Ehrman, MD
Contact
rehrman@med.wayne.edu
313-5771268
Laura Gowland, Sonographer
Contact
lgowland@med.wayne.edu
313-5771268
Robert Ehrman, MD
principal investigator · Wayne University Emergency medicine
Noa Avisar, PhD
study director · UltraSight

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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