<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/NCT03838640</url>
  </required_header>
  <id_info>
    <org_study_id>5450-18-SMC</org_study_id>
    <nct_id>NCT03838640</nct_id>
  </id_info>
  <brief_title>Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery</brief_title>
  <official_title>Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Identification and preservation of internal carotid artery during endoscopic&#xD;
      nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery,&#xD;
      especially when anatomy is distorted by previous radiation. Intraoperative navigation based&#xD;
      on preoperative imaging cannot remain precise throughout the process of resection. We aim to&#xD;
      check a feasibility of internal carotid artery localization with the help of transnasal&#xD;
      ultrasonic scanning. The most appropriate for this method existing device is an&#xD;
      echocardiography system with pediatric transesophageal transducer.&#xD;
&#xD;
      We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal&#xD;
      disease. After initiatioin of general anesthesia and local decongestion, transducer will be&#xD;
      placed transnasally to nasopharynx in order to scan a parapharyngeal space.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2019</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>distance from nasopharynx surface to a closest wall of internal carotid arter</measure>
    <time_frame>3 minutes</time_frame>
    <description>cm</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>To Assess Feasibility of the New Application</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EPIQ 5</intervention_name>
    <description>As described in summary Trade name of the device Philips EPIQ 5</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Indication for endoscopic nose and paranasal sinuses surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous nasopharyngeal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Arkadi Yakirevitch</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share</ipd_description>
  </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/NCT03838640
org study id: 5450-18-SMC
nct id: NCT03838640
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Identification and preservation of internal carotid artery during endoscopic
      nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery,
      especially when anatomy is distorted by previous radiation. Intraoperative navigation based
      on preoperative imaging cannot remain precise throughout the process of resection. We aim to
      check a feasibility of internal carotid artery localization with the help of transnasal
      ultrasonic scanning. The most appropriate for this method existing device is an
      echocardiography system with pediatric transesophageal transducer.

      We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal
      disease. After initiatioin of general anesthesia and local decongestion, transducer will be
      placed transnasally to nasopharynx in order to scan a parapharyngeal space.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: distance from nasopharynx surface to a closest wall of internal carotid arter
time frame: 3 minutes
description: cm
arm group label: Study group
arm group type: Experimental
description: Consecutive eligible patients requiring endoscopic surgery for sinonasal pathology Transnasal localization of internal carotid artery with TEE ECHO device will be performed
intervention type: Device
intervention name: EPIQ 5
description: As described in summary Trade name of the device Philips EPIQ 5
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Arkadi Yakirevitch
investigator title: Principal Investigator
sharing ipd: No
ipd description: No plans to share