<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/NCT04457167</url>
  </required_header>
  <id_info>
    <org_study_id>RMR-IPC 2017-039</org_study_id>
    <secondary_id>2020-A01644-35</secondary_id>
    <nct_id>NCT04457167</nct_id>
  </id_info>
  <brief_title>Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.</brief_title>
  <acronym>RMR</acronym>
  <official_title>Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to&#xD;
      recruit a total of 480 patients, including 240 patients receiving mastectomy with&#xD;
      preservation of the nipple-areola complex and 240 patients with a reconstruction with&#xD;
      latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to&#xD;
      recruit a total of 480 patients, including 240 patients receiving mastectomy with&#xD;
      preservation of the nipple-areola complex and 240 patients with a reconstruction with&#xD;
      latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Phase III, non-randomized, monocentric, observational, prospective trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of postoperative early complications</measure>
    <time_frame>90 days</time_frame>
    <description>To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Mastectomy</condition>
  <condition>Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Robotic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non robotic surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot-assisted</intervention_name>
    <description>robot-assisted surgery</description>
    <arm_group_label>Robotic surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Not robot-assisted surgery</intervention_name>
    <description>Not robot-assisted surgery</description>
    <arm_group_label>Non robotic surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old,&#xD;
&#xD;
          2. Signed consent to participate,&#xD;
&#xD;
          3. Women with breast cancer over 18 or at high risk of breast cancer (BRCA 1-2 mutations,&#xD;
             PALB2, extensive border lesions)&#xD;
&#xD;
          4. Mastectomy with conservation of the areolo-mammary plaque, or mastectomy without&#xD;
             conservation of the areolo-mammary plaque and conservation of the skin case&#xD;
&#xD;
          5. Mastectomy without conservation of the areolo-mammary plate, immediate breast&#xD;
             reconstruction by prosthesis,&#xD;
&#xD;
          6. immediate breast reconstruction by autologous latissimus dorsi flap&#xD;
&#xD;
          7. immediate breast reconstruction by latissimus dorsi flap and prosthesis,&#xD;
&#xD;
          8. secondary breast reconstruction by latissimus dorsi flap&#xD;
&#xD;
          9. Affiliation to, or beneficiary of, a social security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient under 18,&#xD;
&#xD;
          2. Pregnant woman or likely to be (without effective contraception) or breastfeeding,&#xD;
&#xD;
          3. Person in emergency situation, adult person subject to a legal protection measure&#xD;
             (adult under guardianship, curatorship or safeguard of justice), or out of state to&#xD;
             express his consent,&#xD;
&#xD;
          4. Inability to submit to medical follow-up for the trial for geographic, social or&#xD;
             psychological reasons.&#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>Gilles Houvenaeghel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Genre</last_name>
    <phone>33491223778</phone>
    <email>DRCI.UP@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Margot Berline</last_name>
    <phone>33491223778</phone>
    <email>DRCI.UP@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>robot-assisted</keyword>
  <keyword>mini-invasive surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04457167
org study id: RMR-IPC 2017-039
secondary id: 2020-A01644-35
nct id: NCT04457167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to
      recruit a total of 480 patients, including 240 patients receiving mastectomy with
      preservation of the nipple-areola complex and 240 patients with a reconstruction with
      latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to
      recruit a total of 480 patients, including 240 patients receiving mastectomy with
      preservation of the nipple-areola complex and 240 patients with a reconstruction with
      latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Phase III, non-randomized, monocentric, observational, prospective trial.
primary purpose: Treatment
masking: None (Open Label)
measure: rate of postoperative early complications
time frame: 90 days
description: To assess the value of robotic surgery for breast mastectomy with preservation of the nipple-areola complex and immediate or delayed reconstruction by latissimus dorsi flap, with an evaluation of the rate of postoperative early complications (90 postoperative days)
arm group label: Robotic surgery
arm group type: Experimental
description: Robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,
arm group label: Non robotic surgery
arm group type: Active Comparator
description: Non-robotic surgery for breast mastectomy with conservation of areolo-nipple plate and immediate or delayed reconstruction by latissimus dorsi flap,
intervention type: Device
intervention name: Robot-assisted
description: robot-assisted surgery
arm group label: Robotic surgery
intervention type: Procedure
intervention name: Not robot-assisted surgery
description: Not robot-assisted surgery
arm group label: Non robotic surgery
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Houvenaeghel
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: Dominique Genre
phone: 33491223778
email: DRCI.UP@ipc.unicancer.fr
last name: Margot Berline
phone: 33491223778
email: DRCI.UP@ipc.unicancer.fr
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No