<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041168</url>
  </required_header>
  <id_info>
    <org_study_id>16G.774</org_study_id>
    <nct_id>NCT03041168</nct_id>
  </id_info>
  <brief_title>Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors</brief_title>
  <official_title>Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CVR Global, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed&#xD;
      by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will&#xD;
      compare a new application of a technology, the CSS device, to reference standards for&#xD;
      assessment of carotid disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS)&#xD;
      can accurately detect significant carotid artery stenosis.&#xD;
&#xD;
      Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We&#xD;
      obtain a &quot;proof of concept&quot; if the device correlates strongly with the established&#xD;
      classification of atherosclerotic carotid disease derived various imaging modalities&#xD;
      including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA),&#xD;
      conventional angiography, or carotid ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was stopped due to suspension of funding from CVR Global.&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound</measure>
    <time_frame>CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between percent carotid artery stenosis measured by CSS and by carotid CTA</measure>
    <time_frame>CSS reported percentage of carotid stenosis within 30 days of carotid CTA</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between percent carotid artery stenosis measured by CSS and by carotid MRA</measure>
    <time_frame>CSS reported percentage of carotid stenosis within 30 days of carotid MRA</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between percent carotid artery stenosis measured by CSS and carotid angiogram</measure>
    <time_frame>CSS reported percentage of carotid stenosis within 30 days of carotid angiogram</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">414</enrollment>
  <condition>Carotid Artery Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Carotid Stenotic Scan</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of patients presenting to a Jefferson facility for&#xD;
        carotid imaging studies. Subjects scheduled for carotid artery assessments will be&#xD;
        identified prior to the day of study using radiology scheduling.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects over 18 referred for carotid duplex ultrasound.&#xD;
&#xD;
          -  Subjects over 18 referred for CT angiography, MR angiography, or conventional&#xD;
             angiography of the carotid arteries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of carotid endarterectomy, carotid artery stent&#xD;
&#xD;
          -  Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)&#xD;
&#xD;
          -  Patients with prosthetic heart valve&#xD;
&#xD;
          -  Patients unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David J Whellan, MD MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Artery Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041168
org study id: 16G.774
nct id: NCT03041168
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: 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
measure: 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
measure: 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
measure: 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
intervention type: Device
intervention name: Carotid Stenotic Scan
description: 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 pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David J Whellan, MD MHS
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
sharing ipd: No