Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
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|ClinicalTrials.gov Identifier: NCT03041168|
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2017
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment|
|Carotid Artery Disease||Device: Carotid Stenotic Scan|
The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.
Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
- Device: Carotid Stenotic Scan
Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.
- Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound ]
- Difference between percent carotid artery stenosis measured by CSS and by carotid CTA [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid CTA ]
- Difference between percent carotid artery stenosis measured by CSS and by carotid MRA [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid MRA ]
- Difference between percent carotid artery stenosis measured by CSS and carotid angiogram [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid angiogram ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041168
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||David J Whellan, MD MHS||Thomas Jefferson University|