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Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041168
Recruitment Status : Enrolling by invitation
First Posted : February 2, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
CVR Global, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.

Condition or disease Intervention/treatment
Carotid Artery Disease Device: Carotid Stenotic Scan

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients presenting to a Jefferson facility for carotid imaging studies. Subjects scheduled for carotid artery assessments will be identified prior to the day of study using radiology scheduling.
Criteria

Inclusion Criteria:

  • Subjects over 18 referred for carotid duplex ultrasound.
  • Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries

Exclusion Criteria:

  • Previous history of carotid endarterectomy, carotid artery stent
  • Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)
  • Patients with prosthetic heart valve
  • Patients unable to provide informed consent.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
CVR Global, Inc.
Investigators
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Principal Investigator: David J Whellan, MD MHS Thomas Jefferson University
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03041168    
Other Study ID Numbers: 16G.774
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases