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Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

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ClinicalTrials.gov Identifier: NCT03041168
Recruitment Status : Unknown
Verified February 2019 by Thomas Jefferson University.
Recruitment status was:  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

Tracking Information
First Submitted Date January 11, 2017
First Posted Date February 2, 2017
Last Update Posted Date February 12, 2019
Study Start Date January 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 31, 2017)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Official Title Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Carotid Artery Disease
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 31, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041168
Other Study ID Numbers 16G.774
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Thomas Jefferson University
Study Sponsor Thomas Jefferson University
Collaborators CVR Global, Inc.
Investigators
Principal Investigator: David J Whellan, MD MHS Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date February 2019