<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/NCT03294213</url>
  </required_header>
  <id_info>
    <org_study_id>CIS-002</org_study_id>
    <nct_id>NCT03294213</nct_id>
  </id_info>
  <brief_title>Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView</brief_title>
  <official_title>Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ambu A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ambu A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as a prospective observational, non-controlled, non-interventional&#xD;
      study.&#xD;
&#xD;
      The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho,&#xD;
      focusing on the device functionalities within regular clinical practice and therapeutic use&#xD;
      of flexible bronchoscopes in the OR and ICU.&#xD;
&#xD;
      The study will include a minimum of 100 adult patients admitted to the operating room (OR) or&#xD;
      Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will&#xD;
      stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.&#xD;
&#xD;
      The involved sites will include patients during a five months' period, from September 2017 to&#xD;
      January 2018.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Refer to brief description&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>User Preference of Scope</measure>
    <time_frame>Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit</time_frame>
    <description>This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">176</enrollment>
  <condition>Bronchoscopy</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>aScope 4 Broncho</arm_group_label>
    <description>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>aScope 4 Broncho</intervention_name>
    <description>Investigator is asked: &quot;In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated&quot; on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use</description>
    <arm_group_label>aScope 4 Broncho</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient's ≥18 years, Clinical indication and eligible for an airway procedure involving a&#xD;
        bronchoscopy procedure, as judged by the Investigator, Patients being admitted in the OR or&#xD;
        ICU at the investigational site&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient's ≥18 years&#xD;
&#xD;
          -  Clinical indication and eligible for an airway procedure involving a bronchoscopy&#xD;
             procedure, as judged by the Investigator&#xD;
&#xD;
          -  Patients being admitted in the OR or ICU at the investigational site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pia Nordmand, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Ambu A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Anästhesiologie, Universitätsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rhineland-Palatinate</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>May 26, 2020</results_first_submitted>
  <results_first_submitted_qc>February 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2021</results_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>October 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03294213/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>aScope 4 Broncho</title>
          <description>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho&#xD;
aScope 4 Broncho: Investigator is asked: &quot;In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated&quot; on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>aScope 4 Broncho</title>
          <description>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho&#xD;
aScope 4 Broncho: Investigator is asked: &quot;In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated&quot; on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="176"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Age Data were not collected</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Sex/Gender data were not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>User Preference of Scope</title>
        <description>This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.</description>
        <time_frame>Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>aScope 4 Broncho</title>
            <description>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho&#xD;
aScope 4 Broncho: Investigator is asked: &quot;In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated&quot; on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use</description>
          </group>
        </group_list>
        <measure>
          <title>User Preference of Scope</title>
          <description>This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Prefer aScope 4 Broncho</title>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer standard bronchoscope</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No preference on bronchoscope</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collected over the course of 5 months, Adverse Events assessed during each procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>aScope 4 Broncho</title>
          <description>The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho&#xD;
aScope 4 Broncho: Investigator is asked: &quot;In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated&quot; on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Poor light</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Freezing image and blackout for 60 seconds</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anna Lundgaard</name_or_title>
      <organization>Ambu A/S</organization>
      <phone>+4529643748</phone>
      <email>aclu@ambu.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03294213
org study id: CIS-002
nct id: NCT03294213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed as a prospective observational, non-controlled, non-interventional
      study.

      The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho,
      focusing on the device functionalities within regular clinical practice and therapeutic use
      of flexible bronchoscopes in the OR and ICU.

      The study will include a minimum of 100 adult patients admitted to the operating room (OR) or
      Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will
      stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.

      The involved sites will include patients during a five months' period, from September 2017 to
      January 2018.
Refer to brief description
observational model: Cohort
time perspective: Prospective
measure: User Preference of Scope
time frame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
description: This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.
arm group label: aScope 4 Broncho
description: The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho
intervention type: Device
intervention name: aScope 4 Broncho
description: Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use
arm group label: aScope 4 Broncho
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Pia Nordmand, MSc
role: Study Chair
affiliation: Ambu A/S
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 