<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/NCT01664052</url>
  </required_header>
  <id_info>
    <org_study_id>17035</org_study_id>
    <secondary_id>ESS505-002</secondary_id>
    <nct_id>NCT01664052</nct_id>
  </id_info>
  <brief_title>ESS505 Pre-hysterectomy Protocol</brief_title>
  <official_title>ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <brief_summary>
    <textblock>
      This study has been designed to evaluate an investigational model of the Essure System for&#xD;
      Permanent Birth Control. The investigational device is designed to offer all the advantages&#xD;
      of the currently approved device. In addition, the investigational device offers immediate,&#xD;
      permanent contraception without a three-month waiting period or 90-day confirmation test.&#xD;
      This study has been designed to evaluate the effectiveness of the investigational device in&#xD;
      causing tubal occlusion from insert placement through three months of wearing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has previously been posted by Conceptus, Inc. (US).&#xD;
&#xD;
      After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation</measure>
    <time_frame>60 minutes after insert placement</time_frame>
    <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation</measure>
    <time_frame>30 days after insert placement</time_frame>
    <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation</measure>
    <time_frame>60 days after insert placement</time_frame>
    <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation</measure>
    <time_frame>90 days after insert placement</time_frame>
    <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>ESS505-A (Essure, BAY1454033)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESS505 (Essure, BAY1454033)</intervention_name>
    <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
    <arm_group_label>ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESS305 (Essure, BAY1454032)</intervention_name>
    <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
    <arm_group_label>ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESS505-A (Essure, BAY1454033)</intervention_name>
    <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
    <arm_group_label>ESS505-A (Essure, BAY1454033)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy&#xD;
             (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total&#xD;
             Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral&#xD;
             Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)&#xD;
&#xD;
          -  Subjects who are 18 years of age and older&#xD;
&#xD;
          -  Subjects who are able and willing to provide written informed consent&#xD;
&#xD;
          -  Subjects who agree to use a contraceptive method following Essure placement until the&#xD;
             hysterectomy procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with bilateral proximal tubal occlusion&#xD;
&#xD;
          -  Subjects who have undergone fallopian tube sterilization&#xD;
&#xD;
          -  Subjects with known endometrial or myometrial pathology which is likely to prevent&#xD;
             access to the fallopian tube ostia&#xD;
&#xD;
          -  Subjects who are post-menopausal&#xD;
&#xD;
          -  Subjects with pelvic inflammatory disease (PID)&#xD;
&#xD;
          -  Subjects with gynecologic malignancy&#xD;
&#xD;
          -  Pregnancy or suspected pregnancy&#xD;
&#xD;
          -  Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert&#xD;
             placement&#xD;
&#xD;
          -  Known allergy to contrast media&#xD;
&#xD;
          -  Any general health condition that may represent, in the opinion of the Investigator,&#xD;
             an increased potential risk associated with participation&#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>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4P 0W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chihuahua</city>
        <zip>31350</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Thiel J, Rattray D, Cher DJ. Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505). J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):1055-60. doi: 10.1016/j.jmig.2014.04.020. Epub 2014 May 24.</citation>
    <PMID>24861649</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>February 3, 2016</results_first_submitted>
  <results_first_submitted_qc>May 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 19, 2016</results_first_posted>
  <disposition_first_submitted>March 5, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>March 5, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 2, 2014</disposition_first_posted>
  <last_update_submitted>July 6, 2016</last_update_submitted>
  <last_update_submitted_qc>July 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>66 participants were enrolled in two centers.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>ESS505-A (Essure, BAY1454033)</title>
          <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
        </group>
        <group group_id="P2">
          <title>ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)</title>
          <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31">Screening and enrollment</participants>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Insert Placed in at Least One Tube</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>HSG 1 Hour Post Placement</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 30 Days</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 60 Days</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 90 Days</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No device placement</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No HSG 1 hr post placement</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Phase 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Screened and enrolled</participants>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Insert Placed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>HSG 1 Hour Post Placement</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 30 Days</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 60 Days</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Repeat HSG and Hysterectomy at 90 Days</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No device placement</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ESS505-A</title>
          <description>Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).</description>
        </group>
        <group group_id="B2">
          <title>ESS305/ESS505</title>
          <description>Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" lower_limit="31" upper_limit="49"/>
                    <measurement group_id="B2" value="40" lower_limit="28" upper_limit="52"/>
                    <measurement group_id="B3" value="41" lower_limit="28" upper_limit="52"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation</title>
        <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.</description>
        <time_frame>60 minutes after insert placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ESS505-A (Essure, BAY1454033)</title>
            <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
          </group>
          <group group_id="O2">
            <title>ESS305 (Essure, BAY1454032)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
          <group group_id="O3">
            <title>ESS505 (Essure, BAY1454033)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation</title>
          <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.</description>
          <units>Occluded fallopian tubes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Fallopian tubes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ESS505-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="NA">ESS505-A not investigated in this group</measurement>
                    <measurement group_id="O3" value="NA">ESS505-A not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS305</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS305 not investigated in this group</measurement>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="NA">ESS305 not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS505</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O2" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation</title>
        <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
        <time_frame>30 days after insert placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ESS505-A (Essure, BAY1454033)</title>
            <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
          </group>
          <group group_id="O2">
            <title>ESS305 (Essure, BAY1454032)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
          <group group_id="O3">
            <title>ESS505 (Essure, BAY1454033)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation</title>
          <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
          <units>Occluded fallopian tubes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Fallopian tubes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ESS505-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="NA">ESS505-A not investigated in this group</measurement>
                    <measurement group_id="O3" value="NA">ESS505-A not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS305</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS305 not investigated in this group</measurement>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="NA">ESS305 not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS505</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O2" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation</title>
        <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
        <time_frame>60 days after insert placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ESS505-A (Essure, BAY1454033)</title>
            <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
          </group>
          <group group_id="O2">
            <title>ESS305 (Essure, BAY1454032)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
          <group group_id="O3">
            <title>ESS505 (Essure, BAY1454033)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation</title>
          <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
          <units>Occluded fallopian tubes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Fallopian tubes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ESS505-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="NA">ESS505-A not investigated in this group</measurement>
                    <measurement group_id="O3" value="NA">ESS505-A not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS305</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS305 not investigated in this group</measurement>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="NA">ESS305 not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS505</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O2" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation</title>
        <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
        <time_frame>90 days after insert placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ESS505-A (Essure, BAY1454033)</title>
            <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
          </group>
          <group group_id="O2">
            <title>ESS305 (Essure, BAY1454032)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
          <group group_id="O3">
            <title>ESS505 (Essure, BAY1454033)</title>
            <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation</title>
          <description>Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.</description>
          <units>Occluded fallopian tubes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Fallopian tubes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ESS505-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="NA">ESS505-A not investigated in this group</measurement>
                    <measurement group_id="O3" value="NA">ESS505-A not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS305</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS305 not investigated in this group</measurement>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="NA">ESS305 not investigated in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ESS505</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O2" value="NA">ESS505 not investigated in this group</measurement>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected after signing the informed consent up to 90 days after insert placement.</time_frame>
      <desc>The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>ESS505-A (Essure, BAY1454033)</title>
          <description>Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.</description>
        </group>
        <group group_id="E2">
          <title>ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)</title>
          <description>Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sensation of pressure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </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>A PI may be requested to delay results communications up to 18 months following study conclusion or until a summary of all study results initiated by Sponsor (first publication) has been published. Following first publication embargo, sponsor may review results communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor may request a postponement of results communications not to exceed 180 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>BAYER</organization>
      <email>clinical-trials-contact@bayerhealthcare.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/NCT01664052
org study id: 17035
secondary id: ESS505-002
nct id: NCT01664052
lead sponsor: 
This study has been designed to evaluate an investigational model of the Essure System for
      Permanent Birth Control. The investigational device is designed to offer all the advantages
      of the currently approved device. In addition, the investigational device offers immediate,
      permanent contraception without a three-month waiting period or 90-day confirmation test.
      This study has been designed to evaluate the effectiveness of the investigational device in
      causing tubal occlusion from insert placement through three months of wearing.
This study has previously been posted by Conceptus, Inc. (US).

      After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation
time frame: 60 minutes after insert placement
description: Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.
measure: Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation
time frame: 30 days after insert placement
description: Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
measure: Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation
time frame: 60 days after insert placement
description: Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
measure: Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation
time frame: 90 days after insert placement
description: Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
arm group label: ESS505-A (Essure, BAY1454033)
arm group type: Experimental
description: Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
arm group label: ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
arm group type: Experimental
description: Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
intervention type: Device
intervention name: ESS505 (Essure, BAY1454033)
description: Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
arm group label: ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
intervention type: Device
intervention name: ESS305 (Essure, BAY1454032)
description: Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
arm group label: ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
intervention type: Device
intervention name: ESS505-A (Essure, BAY1454033)
description: Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
arm group label: ESS505-A (Essure, BAY1454033)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
country: Canada
country: Mexico
citation: Thiel J, Rattray D, Cher DJ. Pre-hysterectomy assessment of immediate tubal occlusion with the third-generation ESSURE insert (ESS505). J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):1055-60. doi: 10.1016/j.jmig.2014.04.020. Epub 2014 May 24.
PMID: 24861649
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 