<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/NCT02222675</url>
  </required_header>
  <id_info>
    <org_study_id>MAC-001_1.1</org_study_id>
    <nct_id>NCT02222675</nct_id>
  </id_info>
  <brief_title>Conserving Breast Surgery - Comparison of Conventional With Sonography</brief_title>
  <acronym>MAC-001</acronym>
  <official_title>Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Women's Hospital Tübingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Women's Hospital Tübingen</source>
  <brief_summary>
    <textblock>
      Aim of the study is to test whether surgical removal of a tumor under sonographic control as&#xD;
      compared to conventional method reduces the rate of resections and local relapse&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of second tumor resections</measure>
    <time_frame>Five years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Breast Surgery</condition>
  <arm_group>
    <arm_group_label>Sonographically assisted breast surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sonographically assisted breast surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional breast surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional breast surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sonography assisted breast surgery</intervention_name>
    <arm_group_label>Sonographically assisted breast surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional breast surgery</intervention_name>
    <arm_group_label>Conventional breast surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 70 years&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Presurgical validated breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sonographically not defined report&#xD;
&#xD;
          -  Lobular breast cancer&#xD;
&#xD;
          -  Extensive ductal carcinoma in situ&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Women's Hospital</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02222675
org study id: MAC-001_1.1
nct id: NCT02222675
lead sponsor: 
Aim of the study is to test whether surgical removal of a tumor under sonographic control as
      compared to conventional method reduces the rate of resections and local relapse
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rate of second tumor resections
time frame: Five years
arm group label: Sonographically assisted breast surgery
arm group type: Experimental
description: Sonographically assisted breast surgery
arm group label: Conventional breast surgery
arm group type: Active Comparator
description: Conventional breast surgery
intervention type: Procedure
intervention name: Sonography assisted breast surgery
arm group label: Sonographically assisted breast surgery
intervention type: Procedure
intervention name: Conventional breast surgery
arm group label: Conventional breast surgery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor