Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

NCT03041168 | Terminated FDA Device

• 1 other identifier: 16G.774
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

• Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound

  CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound

Secondary Outcomes (3)

• Difference between percent carotid artery stenosis measured by CSS and by carotid CTA

  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

  CSS reported percentage of carotid stenosis within 30 days of carotid MRA

• Difference between percent carotid artery stenosis measured by CSS and carotid angiogram

  CSS reported percentage of carotid stenosis within 30 days of carotid angiogram

Interventions

Carotid Stenotic Scan DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• CVR Global, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David J Whellan, MD MHS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)