xml: <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/NCT06006078</url>
    </required_header>
    <id_info>
      <org_study_id>21-641</org_study_id>
      <nct_id>NCT06006078</nct_id>
    </id_info>
    <brief_title>Aersosolization During Upper Endoscopy</brief_title>
    <official_title>Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during&#xD;
        upper endoscopy the investigators are conducting a randomized controlled trial seeking to&#xD;
        assess both the level of aerosolization that occurs during these procedures along with&#xD;
        determining if utilization of an endoscopic patient face-masks reduces the level of&#xD;
        aerosolized particles. The protocol includes the use of a commercially available particle&#xD;
        counter the investigators are employing for the measurement of aerosols before, during, and&#xD;
        after anesthesia assisted upper endoscopic procedures. The investigators are recruiting&#xD;
        patients undergoing these procedures with a target of 30 patients undergoing endoscopy&#xD;
        without a facemask and 30 patients undergoing endoscopy with one.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 31, 2021</start_date>
    <completion_date type="Actual">October 15, 2021</completion_date>
    <primary_completion_date type="Actual">October 15, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Aersolization of particles during upper endoscopy</measure>
      <time_frame>Start of endoscopy through the end of endoscopy</time_frame>
      <description>Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Infectious</condition>
    <condition>Gastro-Intestinal Disorder</condition>
    <condition>Safety Issues</condition>
    <arm_group>
      <arm_group_label>Endoscopic Facemask</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients undergoing endoscopy with the use of an endoscopic facemask</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Endoscopic Facemask</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients undergoing endoscopy without an endoscopic facemask</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endoscopic Patient Facemask</intervention_name>
      <description>A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization</description>
      <arm_group_label>Endoscopic Facemask</arm_group_label>
      <other_name>POM Mask</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP,&#xD;
               endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic&#xD;
               inpatient endoscopy unit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any patient requiring endotracheal intubation&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  Emergency procedures&#xD;
  &#xD;
            -  Patients who require use of a facemask before or during the procedure due to medical&#xD;
               necessity&#xD;
  &#xD;
            -  Patients under the age of 18&#xD;
  &#xD;
            -  Non-English speaking individuals&#xD;
  &#xD;
            -  Patients unable to provide consent.&#xD;
  &#xD;
            -  Any procedure done outside the designated procedure room.&#xD;
  &#xD;
            -  If in the opinion of the anesthesiologist, a subject who was randomized to the control&#xD;
               arm requires placement of the procedural mask to augment oxygenation, the subject will&#xD;
               be removed from the study&#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>John Vargo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Physician</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cleveland Clinic Foundation</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>John Vargo</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 2, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT06006078/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>October 21, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT06006078/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006078
  org study id: 21-641
  nct id: NCT06006078
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during
        upper endoscopy the investigators are conducting a randomized controlled trial seeking to
        assess both the level of aerosolization that occurs during these procedures along with
        determining if utilization of an endoscopic patient face-masks reduces the level of
        aerosolized particles. The protocol includes the use of a commercially available particle
        counter the investigators are employing for the measurement of aerosols before, during, and
        after anesthesia assisted upper endoscopic procedures. The investigators are recruiting
        patients undergoing these procedures with a target of 30 patients undergoing endoscopy
        without a facemask and 30 patients undergoing endoscopy with one.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Aersolization of particles during upper endoscopy
  time frame: Start of endoscopy through the end of endoscopy
  description: Comparing the aersolization of particles of six different sizes during endoscopy between patients using an endoscopic facemask to those without.
  arm group label: Endoscopic Facemask
  arm group type: Active Comparator
  description: Patients undergoing endoscopy with the use of an endoscopic facemask
  arm group label: No Endoscopic Facemask
  arm group type: No Intervention
  description: Patients undergoing endoscopy without an endoscopic facemask
  intervention type: Device
  intervention name: Endoscopic Patient Facemask
  description: A commonly used endoscopic patient facemask that is normally used for oxygen delivery during endoscopy will be tested in this trial as a potential intervention for decreasing particle aerosolization
  arm group label: Endoscopic Facemask
  other name: POM Mask
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John Vargo, MD
  role: Principal Investigator
  affiliation: Physician
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: John Vargo
  investigator title: MD
  mesh term: Intestinal Diseases
  mesh term: Gastrointestinal Diseases
  mesh term: Digestive System Diseases
  sharing ipd: No
  provided document: 
  provided document: 