<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/NCT01675011</url>
  </required_header>
  <id_info>
    <org_study_id>2010-001</org_study_id>
    <nct_id>NCT01675011</nct_id>
  </id_info>
  <brief_title>Embozene Microspheres for Uterine Fibroid Embolization (UFE)</brief_title>
  <official_title>Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years&#xD;
      with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six&#xD;
      (36) months following uterine fibroid embolization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inadequate enrollment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Endpoint</measure>
    <time_frame>12 Months post study procedure</time_frame>
    <description>The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Uterine Fibroids</condition>
  <arm_group>
    <arm_group_label>Embozene® Microspheres</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Embosphere®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embozene® Microspheres</intervention_name>
    <arm_group_label>Embozene® Microspheres</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embosphere®</intervention_name>
    <arm_group_label>Embosphere®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is able to provide informed consent and must sign the Institutional Review&#xD;
             Board approved Informed Consent Form.&#xD;
&#xD;
          -  Pre-menopausal women age 30-50 years at time of enrollment&#xD;
&#xD;
          -  Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a history of pelvic malignancy&#xD;
&#xD;
          -  Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid&#xD;
             Embolization procedure&#xD;
&#xD;
          -  Patient with coexisting condition that might explain abnormal bleeding (including&#xD;
             endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and&#xD;
             ovarian cysts).&#xD;
&#xD;
          -  Is at substantial risk for the need of organ transplantation, such as renal&#xD;
             insufficiency.&#xD;
&#xD;
          -  Patient has evidence of current or recent pelvic inflammatory disease or uterine&#xD;
             infection.&#xD;
&#xD;
          -  Patient with a severe contrast allergy or renal insufficiency that would represent a&#xD;
             contradiction to the administration of iodine-based contrast agents.&#xD;
&#xD;
          -  Patients unable to comply with the follow-up requirements of the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore LIJ Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <results_first_submitted>January 28, 2015</results_first_submitted>
  <results_first_submitted_qc>January 28, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 12, 2015</results_first_posted>
  <last_update_submitted>February 10, 2016</last_update_submitted>
  <last_update_submitted_qc>February 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>11 patients screened and 4 randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Embozene® Microspheres</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embozene® Microspheres</description>
        </group>
        <group group_id="P2">
          <title>Embosphere®</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embosphere®</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Trial terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Embozene® Microspheres</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embozene® Microspheres</description>
        </group>
        <group group_id="B2">
          <title>Embosphere®</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embosphere®</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="3"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="4"/>
          </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="45" lower_limit="40" upper_limit="49"/>
                    <measurement group_id="B2" value="45" lower_limit="45" upper_limit="45"/>
                    <measurement group_id="B3" value="45" lower_limit="40" upper_limit="49"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</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>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <title>Unknown or Not Reported</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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Endpoint</title>
        <description>The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.</description>
        <time_frame>12 Months post study procedure</time_frame>
        <population>The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Embozene® Microspheres</title>
            <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embozene® Microspheres</description>
          </group>
          <group group_id="O2">
            <title>Embosphere®</title>
            <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embosphere®</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Endpoint</title>
          <description>The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.</description>
          <population>The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 through 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Embozene® Microspheres</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embozene® Microspheres</description>
        </group>
        <group group_id="E2">
          <title>Embosphere®</title>
          <description>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.&#xD;
Embosphere®</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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>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="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The trial was terminated early due to insufficient enrollment, therefore formal statistical analyses were not possible.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Anastasia Becker - Director of Clinical Trials</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>763-494-2170</phone>
      <email>Ana.Becker@bsci.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/NCT01675011
org study id: 2010-001
nct id: NCT01675011
lead sponsor: 
has dmc: Yes
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years
      with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six
      (36) months following uterine fibroid embolization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Primary Endpoint
time frame: 12 Months post study procedure
description: The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.
arm group label: Embozene® Microspheres
arm group type: Experimental
description: Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
arm group label: Embosphere®
arm group type: Active Comparator
description: Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
intervention type: Device
intervention name: Embozene® Microspheres
arm group label: Embozene® Microspheres
intervention type: Device
intervention name: Embosphere®
arm group label: Embosphere®
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The trial was terminated early due to insufficient enrollment, therefore formal statistical analyses were not possible.
point of contact: 