xml: <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/NCT06032962</url>
    </required_header>
    <id_info>
      <org_study_id>MeirMedicalCenter</org_study_id>
      <nct_id>NCT06032962</nct_id>
    </id_info>
    <brief_title>Opportunistic Salpingectomy in Non-gynecological Surgeries</brief_title>
    <official_title>Opportunistic Salpingectomy in Non-gynecological Surgeries - a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dana Josephy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Meir Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy&#xD;
        (OS) and procedure feasibility in non gynecological abdominal surgeries&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree,&#xD;
        a general surgeon perform the procedure during the planned abdominal surgery&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">February 28, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>patients willing for salpingectomy</measure>
      <time_frame>day of enrollment</time_frame>
      <description>The number of patients that will agree for salpingectomy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>patients undergoing salpingectomy</measure>
      <time_frame>from enrollment and up to 6 weeks</time_frame>
      <description>The number of patients that will undergo salpingectomy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>length of salpingectomy</measure>
      <time_frame>within surgery</time_frame>
      <description>the length (in minutes) of salpingectomy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>surgical complications</measure>
      <time_frame>up to 30 days from surgery</time_frame>
      <description>complications during or after salpingectomy</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">42</enrollment>
    <condition>Ovarian Cancer Prevention</condition>
    <arm_group>
      <arm_group_label>non-gynecologic surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Female candidates for non-gynecologic abdominal surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>salpingectomy</intervention_name>
      <description>surgical removal of the fallopian tubes</description>
      <arm_group_label>non-gynecologic surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who were candidates for non-gynecological abdominal surgery&#xD;
  &#xD;
            -  Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Candidates for urgent surgery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Meir medical center</name>
        <address>
          <city>Kfar Saba</city>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Meir Medical Center</investigator_affiliation>
      <investigator_full_name>Dana Josephy</investigator_full_name>
      <investigator_title>Dana Josephy</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032962
  org study id: MeirMedicalCenter
  nct id: NCT06032962
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy
        (OS) and procedure feasibility in non gynecological abdominal surgeries
  Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree,
        a general surgeon perform the procedure during the planned abdominal surgery
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: patients willing for salpingectomy
  time frame: day of enrollment
  description: The number of patients that will agree for salpingectomy
  measure: patients undergoing salpingectomy
  time frame: from enrollment and up to 6 weeks
  description: The number of patients that will undergo salpingectomy
  measure: length of salpingectomy
  time frame: within surgery
  description: the length (in minutes) of salpingectomy
  measure: surgical complications
  time frame: up to 30 days from surgery
  description: complications during or after salpingectomy
  arm group label: non-gynecologic surgery
  arm group type: Experimental
  description: Female candidates for non-gynecologic abdominal surgery
  intervention type: Procedure
  intervention name: salpingectomy
  description: surgical removal of the fallopian tubes
  arm group label: non-gynecologic surgery
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Israel
  responsible party type: Sponsor-Investigator
  investigator affiliation: Meir Medical Center
  investigator full name: Dana Josephy
  investigator title: Dana Josephy