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/NCT05977751</url>
    </required_header>
    <id_info>
      <org_study_id>CP-100-009</org_study_id>
      <nct_id>NCT05977751</nct_id>
    </id_info>
    <brief_title>Prospective Multi-Center Trial for FemBloc Permanent Birth Control</brief_title>
    <acronym>FINALE</acronym>
    <official_title>FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Femasys Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Femasys Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing&#xD;
        FemBloc followed by ultrasound confirmation test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2031</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pregnancy Rate</measure>
      <time_frame>one (1) year</time_frame>
      <description>Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reliance Rate</measure>
      <time_frame>ninety (90) days post treatment</time_frame>
      <description>Number of subjects who were told to rely on FemBloc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long term Pregnancy Rate</measure>
      <time_frame>Five (5) years</time_frame>
      <description>Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">573</enrollment>
    <condition>Contraception</condition>
    <arm_group>
      <arm_group_label>FemBloc</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Investigational device and procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FemBloc</intervention_name>
      <description>Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.</description>
      <arm_group_label>FemBloc</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female, 21 - 50 years of age desiring permanent birth control.&#xD;
  &#xD;
            -  Sexually active with male partner.&#xD;
  &#xD;
            -  Regular menstrual cycle for last 3 months or on hormonal contraceptives.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncertainty about the desire to end fertility.&#xD;
  &#xD;
            -  Known or suspected pregnancy.&#xD;
  &#xD;
            -  Prior tubal surgery, including sterilization attempt.&#xD;
  &#xD;
            -  Presence, suspicion, or previous history of gynecologic malignancy.&#xD;
  &#xD;
            -  Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation)&#xD;
               at the time of either FemBloc Treatment or prior to final confirmation test.&#xD;
  &#xD;
            -  Abnormal uterine bleeding requiring evaluation or treatment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Sponsor</last_name>
      <role>Study Director</role>
      <affiliation>Medical Affairs and Clinical Development</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Director</last_name>
      <phone>770-500-3910 Ext. 146</phone>
      <email>StudySupport@Femasys.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Midtown OB GYN North</name>
        <address>
          <city>Columbus</city>
          <state>Georgia</state>
          <zip>31909</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Research Coordinator</last_name>
        <phone>706-320-2547</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Seven Hills Women's Health Centers</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45242</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Research Coordinator</last_name>
        <phone>513-290-3221</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.fembloc.com/</url>
      <description>FemBloc Clinical Study Website</description>
    </link>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Permanent Birth Control</keyword>
    <keyword>Permanent Contraception</keyword>
    <keyword>Permanent Sterilization</keyword>
    <!-- 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/NCT05977751
  org study id: CP-100-009
  nct id: NCT05977751
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing
        FemBloc followed by ultrasound confirmation test.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Pregnancy Rate
  time frame: one (1) year
  description: Number of subjects who were told to rely on FemBloc for birth control and became pregnant through one (1) year.
  measure: Reliance Rate
  time frame: ninety (90) days post treatment
  description: Number of subjects who were told to rely on FemBloc.
  measure: Long term Pregnancy Rate
  time frame: Five (5) years
  description: Number of subjects who were told to rely on FemBloc for birth control that became pregnant after one (1) year through 2-, 3-, 4-, and 5-years.
  arm group label: FemBloc
  arm group type: Experimental
  description: Investigational device and procedure
  intervention type: Device
  intervention name: FemBloc
  description: Treatment for women who desire non-surgical permanent birth control by occlusion of the fallopian tubes.
  arm group label: FemBloc
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 21 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Study Sponsor
  role: Study Director
  affiliation: Medical Affairs and Clinical Development
  last name: Study Director
  phone: 770-500-3910 Ext. 146
  email: StudySupport@Femasys.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.fembloc.com/
  description: FemBloc Clinical Study Website
  responsible party type: Sponsor