Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

• ClinicalTrials.gov Identifier: NCT03041168
• Recruitment Status: Unknown
• First Posted: February 2, 2017
• Last Update Posted: February 12, 2019
• Sponsor: Thomas Jefferson University
• 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

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

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

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