<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/NCT02974842</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN 0276</org_study_id>
    <nct_id>NCT02974842</nct_id>
  </id_info>
  <brief_title>Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance</brief_title>
  <official_title>Cytological Evaluation of Specimens Collected With the MAKO 7 Device in Pre Salpingo-Oophorectomy Subjects for Determination and/or Differentiation of Normal Versus Atypical Versus Malignant Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>nVision Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>nVision Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the ability of the MAKO 7 device to collect various cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to&#xD;
      collect cells from the fallopian tubes for cytological evaluation for determination and/or&#xD;
      differentiation of normal versus atypical versus malignant cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">September 27, 2017</completion_date>
  <primary_completion_date type="Actual">September 27, 2017</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>Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.</measure>
    <time_frame>Up to 60 days post-operatively</time_frame>
    <description>Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>BRCA1 Mutation</condition>
  <condition>BRCA2 Mutation</condition>
  <condition>Atypia Suspicious for Malignancy</condition>
  <arm_group>
    <arm_group_label>Pre-Salpingo-Oophorectomy</arm_group_label>
    <description>Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MAKO 7</intervention_name>
    <description>Hysteroscopic cell sampling</description>
    <arm_group_label>Pre-Salpingo-Oophorectomy</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cell samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put&#xD;
        them at high risk of developing malignancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is medically cleared for surgery&#xD;
&#xD;
          2. Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious&#xD;
             for malignancy or for BRCA1 or BRCA2 mutations&#xD;
&#xD;
          3. Subject must be 18 years of age&#xD;
&#xD;
          4. Subject must be able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to hysteroscopy&#xD;
&#xD;
          2. Acute pelvic inflammatory disease&#xD;
&#xD;
          3. Active or recent lower pelvic infection&#xD;
&#xD;
          4. Pregnancy&#xD;
&#xD;
          5. Delivery or termination of a pregnancy in the past 6 weeks&#xD;
&#xD;
          6. Known tubal obstruction including tubal ligation&#xD;
&#xD;
          7. Invasive carcinoma of the cervix or endometrium&#xD;
&#xD;
          8. Intolerance of anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Surbhi Sarna, B.S.</last_name>
    <role>Study Director</role>
    <affiliation>nVision Medical Corp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>March 27, 2020</results_first_submitted>
  <results_first_submitted_qc>March 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 9, 2020</results_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2020</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>Neoplasms</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>June 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02974842/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation were recruited from three gynecologic oncology centers in the United States.</recruitment_details>
      <pre_assignment_details>This was a single arm study evaluating the feasibility of a novel hysteroscopic catheter to collect cytological samples.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MAKO 7 Group</title>
          <description>Women scheduled for a salpingo-oophorectomy surgery due to suspicious adnexal mass or due to BRCA 1 or BRCA 2 mutation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50">Participants</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failures</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Eligible Participants With Hysteroscopic Attempt</title>
          <description>Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria and none of the exclusion criteria.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.6" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native American or other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic or non-Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reason for Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pelvic mass suspicious for malignancy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>BRCA 1 or BRCA 2 mutations</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.</title>
        <description>Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.</description>
        <time_frame>Up to 60 days post-operatively</time_frame>
        <population>Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results.</population>
        <group_list>
          <group group_id="O1">
            <title>MAKO 7 Group</title>
            <description>Fallopian tubes with adequate cytology samples obtained with MAKO 7 with available surgical histology results.</description>
          </group>
        </group_list>
        <measure>
          <title>Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.</title>
          <description>Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.</description>
          <population>Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results.</population>
          <units>fallopian tubes</units>
          <param>Count of Units</param>
          <units_analyzed>fallopian tubes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>fallopian tubes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Concordant</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Discordant</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study procedure or device related adverse events were recorded until 24 hours post study procedure or until discharge, whichever happened first.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MAKO 7 Group</title>
          <description>Women scheduled for salpingo-oophorectomy who provided consent and met all inclusion criteria.</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="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="25" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hematological Dyscrasia</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Electrolyte Imbalance</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine perforation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <description>Not related to study procedure or study device</description>
                <counts group_id="E1" events="24" subjects_affected="22" subjects_at_risk="42"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Surbhi Sarna</name_or_title>
      <organization>nVision Medical</organization>
      <phone>408 655 3577</phone>
      <email>surbhi@nvisionmedical.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/NCT02974842
org study id: CLIN 0276
nct id: NCT02974842
lead sponsor: 
has dmc: No
This study evaluates the ability of the MAKO 7 device to collect various cells
Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to
      collect cells from the fallopian tubes for cytological evaluation for determination and/or
      differentiation of normal versus atypical versus malignant cells.
observational model: Case-Only
time perspective: Prospective
measure: Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
time frame: Up to 60 days post-operatively
description: Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.
arm group label: Pre-Salpingo-Oophorectomy
description: Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy.
intervention type: Device
intervention name: MAKO 7
description: Hysteroscopic cell sampling
arm group label: Pre-Salpingo-Oophorectomy
Cell samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Surbhi Sarna, B.S.
role: Study Director
affiliation: nVision Medical Corp
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 