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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04981444
Other study ID # 002-20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 22, 2021
Est. completion date September 23, 2022

Study information

Verified date July 2022
Source UltraSight
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date September 23, 2022
Est. primary completion date September 20, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
UltraSight

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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