Optimization of an Automated Ultrasound Cardiac Guidance Tool

NCT ID: NCT04981444

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-22

Study Completion Date

2022-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ultrasound Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UltraSight

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Praveen Mehrotra, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AI ECHO INSIGHT RCT for Automated Echo Reporting
NCT07229300 ENROLLING_BY_INVITATION NA