Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
NCT ID: NCT03041168
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
414 participants
OBSERVATIONAL
2017-01-31
2018-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries
Exclusion Criteria
* Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)
* Patients with prosthetic heart valve
* Patients unable to provide informed consent.
18 Years
ALL
No
Sponsors
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CVR Global, Inc.
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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David J Whellan, MD MHS
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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16G.774
Identifier Type: -
Identifier Source: org_study_id