<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/NCT02194140</url>
  </required_header>
  <id_info>
    <org_study_id>028-14</org_study_id>
    <nct_id>NCT02194140</nct_id>
  </id_info>
  <brief_title>Improvement of Appendix Identification and Appendicitis Diagnosis in us After Administration of Oral Contrast Medium</brief_title>
  <acronym>us</acronym>
  <official_title>Improvement of Appendix Identification and Appendicitis Diagnosis in Ultrasound After Administration of Iodinated Oral Contrast Medium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's&#xD;
      localization by oral administration of iodinated contrast material.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The administration of oral iodinated contrast material might facilitate identification of the&#xD;
      appendix and accurate diagnosis of appendicitis. When indicated will shorten time to CT&#xD;
      examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appendix identification rate on ultrasound</measure>
    <time_frame>At the time of ultrasound examination up to 1 hour</time_frame>
    <description>Positive identification of the appendix by ultrasound croteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improved rate of correctly diagnosed appendicitis</measure>
    <time_frame>At time of surgery or patholoy results if available within 14 days</time_frame>
    <description>Results acording to surgery or patholoy reports</description>
  </secondary_outcome>
  <other_outcome>
    <measure>shortening waiting time for CT</measure>
    <time_frame>At time of CT examination up to 1 hour</time_frame>
    <description>Measuring time from referal to examination</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>oral contrast</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>oral iodinated contrast material</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>oral iodinated contrast material</intervention_name>
    <description>diluted in water</description>
    <arm_group_label>oral contrast</arm_group_label>
    <other_name>telebrix 35</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients in emergency department with right lower quadrant pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under 18 years old&#xD;
&#xD;
          -  pregnant women&#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>Nadir Reindorp, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center Hadera Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nadir Reindorp, MD</last_name>
    <phone>972-50-6246984</phone>
    <email>nadirr@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Nadir Reindorp, MD</last_name>
      <phone>972-50-6246984</phone>
      <email>nadirr@hy.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Nadir Reindorp, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Trout AT, Sanchez R, Ladino-Torres MF, Pai DR, Strouse PJ. A critical evaluation of US for the diagnosis of pediatric acute appendicitis in a real-life setting: how can we improve the diagnostic value of sonography? Pediatr Radiol. 2012 Jul;42(7):813-23. doi: 10.1007/s00247-012-2358-6. Epub 2012 Mar 9.</citation>
    <PMID>22402833</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ultrasound</keyword>
  <keyword>iodinated contrast material</keyword>
  <keyword>computed tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194140
org study id: 028-14
nct id: NCT02194140
lead sponsor: 
has dmc: No
Rate of appendix localization on ultrasound is not high. We suggest a way to improve it's
      localization by oral administration of iodinated contrast material.
The administration of oral iodinated contrast material might facilitate identification of the
      appendix and accurate diagnosis of appendicitis. When indicated will shorten time to CT
      examination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Appendix identification rate on ultrasound
time frame: At the time of ultrasound examination up to 1 hour
description: Positive identification of the appendix by ultrasound croteria
measure: improved rate of correctly diagnosed appendicitis
time frame: At time of surgery or patholoy results if available within 14 days
description: Results acording to surgery or patholoy reports
measure: shortening waiting time for CT
time frame: At time of CT examination up to 1 hour
description: Measuring time from referal to examination
arm group label: oral contrast
arm group type: Other
description: oral iodinated contrast material
intervention type: Other
intervention name: oral iodinated contrast material
description: diluted in water
arm group label: oral contrast
other name: telebrix 35
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadir Reindorp, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center Hadera Israel
last name: Nadir Reindorp, MD
phone: 972-50-6246984
email: nadirr@hy.health.gov.il
facility: 
contact: 
investigator: 
country: Israel
citation: Trout AT, Sanchez R, Ladino-Torres MF, Pai DR, Strouse PJ. A critical evaluation of US for the diagnosis of pediatric acute appendicitis in a real-life setting: how can we improve the diagnostic value of sonography? Pediatr Radiol. 2012 Jul;42(7):813-23. doi: 10.1007/s00247-012-2358-6. Epub 2012 Mar 9.
PMID: 22402833
responsible party type: Sponsor
mesh term: Appendicitis