<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/NCT04447339</url>
  </required_header>
  <id_info>
    <org_study_id>ISI-RoNSM-01</org_study_id>
    <nct_id>NCT04447339</nct_id>
  </id_info>
  <brief_title>Open Nipple Sparing Mastectomy (NSM)</brief_title>
  <acronym>NSM Open</acronym>
  <official_title>A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intuitive Surgical</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 is retrospective, multicenter chart review is to evaluate the complication rates of&#xD;
      prophylactic open NSM procedures through 42 days postoperatively&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is retrospective, multicenter chart review is to evaluate the complication rates of&#xD;
      prophylactic open NSM procedures through 42 days postoperatively&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Endpoint: complication rate</measure>
    <time_frame>IntraOperative period through 42 days postoperatively</time_frame>
    <description>To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>IntraOperative period through 42 days postoperatively</time_frame>
    <description>Ability to completely excise memory gland tissue and preserve Nipple Areola Complex</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Nipple Sparing Mastectomy</condition>
  <arm_group>
    <arm_group_label>Open</arm_group_label>
    <description>Prophylactic NSM cases by Open approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nipple Sparing Mastectomy</intervention_name>
    <description>Prophylactic open NSM procedures</description>
    <arm_group_label>Open</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive subjects that have undergone open NSM procedures for prophylaxis between&#xD;
        January 1 2018 through 42 days prior to IRB approval will be included in this retrospective&#xD;
        chart review.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All female patients that have undergone open prophylactic NSM cases performed between&#xD;
        January 1, 2018 through 42 days prior to IRB approval&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kyle Webb</last_name>
    <phone>408-523-4758</phone>
    <email>kyle.webb@intusurg.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ling Lin</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katherine Kopkash, MD</last_name>
    </contact>
    <investigator>
      <last_name>Katherine Kopkash, MD, FACS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Hosp - Methodist Campus - MN</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mayo CH-MC- MN</last_name>
    </contact>
    <investigator>
      <last_name>James W Jacob, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Queens</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan Kadison, MD</last_name>
    </contact>
    <investigator>
      <last_name>Alan Kadison, MD, FACS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ari Brooks</last_name>
    </contact>
    <investigator>
      <last_name>Ari Brooks, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Univ. of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosa F Hwang, MD, FACS</last_name>
    </contact>
    <investigator>
      <last_name>Rosa F Hwang, MD, FACS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04447339
org study id: ISI-RoNSM-01
nct id: NCT04447339
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is retrospective, multicenter chart review is to evaluate the complication rates of
      prophylactic open NSM procedures through 42 days postoperatively
This is retrospective, multicenter chart review is to evaluate the complication rates of
      prophylactic open NSM procedures through 42 days postoperatively
observational model: Cohort
time perspective: Retrospective
measure: Safety Endpoint: complication rate
time frame: IntraOperative period through 42 days postoperatively
description: To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
measure: Effectiveness
time frame: IntraOperative period through 42 days postoperatively
description: Ability to completely excise memory gland tissue and preserve Nipple Areola Complex
arm group label: Open
description: Prophylactic NSM cases by Open approach
intervention type: Procedure
intervention name: Nipple Sparing Mastectomy
description: Prophylactic open NSM procedures
arm group label: Open
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Webb
phone: 408-523-4758
email: kyle.webb@intusurg.com
last name: Ling Lin
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided