Ultrasound Therapy Clinical Trial
Official title:
Optimization of an Automated Ultrasound Cardiac Guidance Tool
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 |
Verified date | July 2022 |
Source | UltraSight |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
UltraSight |
United States,
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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