<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/NCT03020888</url>
  </required_header>
  <id_info>
    <org_study_id>US-002</org_study_id>
    <nct_id>NCT03020888</nct_id>
    <nct_alias>NCT03019445</nct_alias>
  </id_info>
  <brief_title>Magseed Magnetic Marker Localization</brief_title>
  <official_title>A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endomagnetics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Endomagnetics Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post-marketing study is to provide prospective evidence that the Magseed&#xD;
      and Sentimag® is effective for lesion localization in patients undergoing surgical excision&#xD;
      of a breast lesion and to summarize measures of product safety and performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in&#xD;
      patients undergoing surgical excision of a breast lesion.&#xD;
&#xD;
      Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior&#xD;
      to surgery.&#xD;
&#xD;
      The Magseed marker will be localized using the Sentimag system during surgery and removed&#xD;
      with the lesion.&#xD;
&#xD;
      After the lumpectomy procedure, subjects will be evaluated for safety and patient reported&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Participants With Retrieval of Index Lesion and Magseed</measure>
    <time_frame>Time of surgery on average 16 minutes</time_frame>
    <description>Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Device Related Adverse Events</measure>
    <time_frame>8 weeks</time_frame>
    <description>Rates of device-related adverse events and device-related serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy</measure>
    <time_frame>At the time of marker deployment on average 8.39 minutes</time_frame>
    <description>Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy &amp; Difficult after each marker placement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Markers With Radiological Placement Accuracy Measured as &lt;5mm to Lesion</measure>
    <time_frame>At time of marker deployment on average 8.39 minutes</time_frame>
    <description>Success rate of Magseed placement relative to the lesion (placement accuracy) measured as &lt;5mm to lesion; 5-10mm to lesion; &gt;10 mm to the target</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Re-excision</measure>
    <time_frame>During surgery on average 16 minutes</time_frame>
    <description>Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy</measure>
    <time_frame>At time of surgery on average 16 minutes</time_frame>
    <description>Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Localization - Duration of Localization</measure>
    <time_frame>At time of surgery on average 16 minutes</time_frame>
    <description>Duration of the lumpectomy procedure, time taken to remove the lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy</measure>
    <time_frame>On the day of surgery</time_frame>
    <description>Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Disorders of Breast</condition>
  <condition>Breast Lesions</condition>
  <arm_group>
    <arm_group_label>Magseed and Sentimag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magseed and Sentimag</intervention_name>
    <description>Magseed marker and Sentimag probe for lesion localization</description>
    <arm_group_label>Magseed and Sentimag</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a breast lesion requiring image-guided localization prior to excision.&#xD;
&#xD;
          -  Subjects aged 18 years or more at the time of consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is pregnant or lactating.&#xD;
&#xD;
          -  Subject has pacemaker or other implantable device in the chest wall.&#xD;
&#xD;
          -  Subject has current active infection at the implantation site in the breast (per&#xD;
             investigatordiscretion)&#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>Kelly Hunt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD Anderson</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>August 12, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 15, 2021</results_first_posted>
  <last_update_submitted>January 16, 2021</last_update_submitted>
  <last_update_submitted_qc>January 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</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>Breast Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03020888/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03020888/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Magseed and Sentimag</title>
          <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insurance coverage</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Magseed and Sentimag</title>
          <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="107"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.73" spread="11.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.73" spread="11.58"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                  </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>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.83" spread="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With Retrieval of Index Lesion and Magseed</title>
        <description>Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.</description>
        <time_frame>Time of surgery on average 16 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Retrieval of Index Lesion and Magseed</title>
          <description>Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Device Related Adverse Events</title>
        <description>Rates of device-related adverse events and device-related serious adverse events</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Device Related Adverse Events</title>
          <description>Rates of device-related adverse events and device-related serious adverse events</description>
          <units>Number of device related adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy</title>
        <description>Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy &amp; Difficult after each marker placement.</description>
        <time_frame>At the time of marker deployment on average 8.39 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy</title>
          <description>Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy &amp; Difficult after each marker placement.</description>
          <units>% Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Markers With Radiological Placement Accuracy Measured as &lt;5mm to Lesion</title>
        <description>Success rate of Magseed placement relative to the lesion (placement accuracy) measured as &lt;5mm to lesion; 5-10mm to lesion; &gt;10 mm to the target</description>
        <time_frame>At time of marker deployment on average 8.39 minutes</time_frame>
        <population>107 participants had 124 markers placed</population>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Markers With Radiological Placement Accuracy Measured as &lt;5mm to Lesion</title>
          <description>Success rate of Magseed placement relative to the lesion (placement accuracy) measured as &lt;5mm to lesion; 5-10mm to lesion; &gt;10 mm to the target</description>
          <population>107 participants had 124 markers placed</population>
          <units>percentage of markers</units>
          <param>Number</param>
          <units_analyzed>Markers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Markers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Re-excision</title>
        <description>Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion</description>
        <time_frame>During surgery on average 16 minutes</time_frame>
        <population>malignant breast lesions</population>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Re-excision</title>
          <description>Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion</description>
          <population>malignant breast lesions</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy</title>
        <description>Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise</description>
        <time_frame>At time of surgery on average 16 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy</title>
          <description>Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Localization - Duration of Localization</title>
        <description>Duration of the lumpectomy procedure, time taken to remove the lesion</description>
        <time_frame>At time of surgery on average 16 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Localization - Duration of Localization</title>
          <description>Duration of the lumpectomy procedure, time taken to remove the lesion</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy</title>
        <description>Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy</description>
        <time_frame>On the day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Magseed and Sentimag</title>
            <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy</title>
          <description>Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse vents data was captured from the time the Magseed was implanted to 8 weeks after it was surgically removed during the index procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Magseed and Sentimag</title>
          <description>Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.&#xD;
Marker located during surgery using the Sentimag system, and removed with the lesion.&#xD;
Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization</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="107"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="107"/>
              </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>Dr Matthew Womack</name_or_title>
      <organization>Endomag</organization>
      <phone>+44 7851 247439</phone>
      <email>mwomack@endomag.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/NCT03020888
org study id: US-002
nct id: NCT03020888
nct alias: NCT03019445
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this post-marketing study is to provide prospective evidence that the Magseed
      and Sentimag® is effective for lesion localization in patients undergoing surgical excision
      of a breast lesion and to summarize measures of product safety and performance.
This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in
      patients undergoing surgical excision of a breast lesion.

      Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior
      to surgery.

      The Magseed marker will be localized using the Sentimag system during surgery and removed
      with the lesion.

      After the lumpectomy procedure, subjects will be evaluated for safety and patient reported
      outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of Participants With Retrieval of Index Lesion and Magseed
time frame: Time of surgery on average 16 minutes
description: Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.
measure: Number of Device Related Adverse Events
time frame: 8 weeks
description: Rates of device-related adverse events and device-related serious adverse events
measure: Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy
time frame: At the time of marker deployment on average 8.39 minutes
description: Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.
measure: Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion
time frame: At time of marker deployment on average 8.39 minutes
description: Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target
measure: Percentage of Participants With Re-excision
time frame: During surgery on average 16 minutes
description: Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion
measure: Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy
time frame: At time of surgery on average 16 minutes
description: Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise
measure: Surgical Localization - Duration of Localization
time frame: At time of surgery on average 16 minutes
description: Duration of the lumpectomy procedure, time taken to remove the lesion
measure: Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy
time frame: On the day of surgery
description: Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy
arm group label: Magseed and Sentimag
arm group type: Experimental
description: Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery.
Marker located during surgery using the Sentimag system, and removed with the lesion.
intervention type: Device
intervention name: Magseed and Sentimag
description: Magseed marker and Sentimag probe for lesion localization
arm group label: Magseed and Sentimag
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kelly Hunt, MD
role: Principal Investigator
affiliation: MD Anderson
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 