<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/NCT02971189</url>
  </required_header>
  <id_info>
    <org_study_id>Birmingham WHC</org_study_id>
    <nct_id>NCT02971189</nct_id>
  </id_info>
  <brief_title>Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom</brief_title>
  <acronym>LEADERUK</acronym>
  <official_title>Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Birmingham Women's NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, single-arm, non-randomised study to evaluate the Librata device performance&#xD;
      and acute safety in performing global endometrial ablation in pre-menopausal women with heavy&#xD;
      menstrual bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      4 clinical sits around the UK aim to recruit 40 women into a study to assess the primary&#xD;
      objective of procedure success using the Librata endometrial ablation device, as defined as&#xD;
      device success (completion of treatment cycles according to device specifications) and no&#xD;
      occurrence of intra-procedural complications.&#xD;
&#xD;
      The investigators will also assess the secondary objectives of:&#xD;
&#xD;
        1. Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram&#xD;
&#xD;
        2. Rate of serious adverse device effects through to day 30 post-operatively&#xD;
&#xD;
        3. Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6&#xD;
           and 12 months&#xD;
&#xD;
        4. Rates of patient satisfaction at 6 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.</measure>
    <time_frame>Day of surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>rates of bleeding as measured by menstrual pictogram</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of serious adverse device effects</measure>
    <time_frame>day 30 post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of patient satisfaction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Heavy Menstrual Bleeding</condition>
  <arm_group>
    <arm_group_label>Librata endometrial ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Librata thermal balloon endometrial ablation treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Librata Endometrial Ablation</intervention_name>
    <description>The treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.</description>
    <arm_group_label>Librata endometrial ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Refractory heavy menstrual bleeding with no definable organic cause&#xD;
&#xD;
          2. Female subject from (and including) age 25 to 50 years&#xD;
&#xD;
          3. Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).&#xD;
&#xD;
          4. A minimum menstrual blood loss of&#xD;
&#xD;
               -  Menstrual Pictogram (MP) score of ≥150 for 3 consecutive months prior to study&#xD;
                  enrollment; OR,&#xD;
&#xD;
               -  MP score ≥150 for one month for women who either had:&#xD;
&#xD;
                    -  at least 3 prior months documented failed medical therapy; or&#xD;
&#xD;
                    -  a contraindication to medical therapy; or&#xD;
&#xD;
                    -  refused medical therapy&#xD;
&#xD;
          5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L&#xD;
&#xD;
          6. Not pregnant and no desire to conceive at any time&#xD;
&#xD;
          7. Subject agrees to use a reliable form of contraception. If a hormonal birth control&#xD;
             method is used, the subject must have been on said method for ≥ 3 months prior to&#xD;
             enrollment and agrees to remain on the same hormonal regimen through their study&#xD;
             participation.&#xD;
&#xD;
          8. Able to provide written informed consent using a form that has been approved by the&#xD;
             reviewing IRB/EC&#xD;
&#xD;
          9. Subject agrees to follow-up schedule and data collection requirements&#xD;
&#xD;
         10. Subject is literate or demonstrates an understanding on how to collect menstrual blood&#xD;
             loss products, and use of the Menstrual Pictogram (MP) diary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who have or meet any of the following exclusion criteria will not be enrolled&#xD;
        in the Study:&#xD;
&#xD;
          1. Pregnancy or subject with a desire to become pregnant&#xD;
&#xD;
          2. Endometrial hyperplasia as confirmed by histology&#xD;
&#xD;
          3. Presence of active endometritis&#xD;
&#xD;
          4. Active pelvic inflammatory disease&#xD;
&#xD;
          5. Active sexually transmitted disease (STD), at the time of ablation.&#xD;
&#xD;
               -  Note: Treatment of STD documented in the chart serves as sufficient evidence of&#xD;
                  infection resolution. Subject may be considered for study enrollment.&#xD;
&#xD;
          6. Presence of bacteraemia, sepsis, or other active systemic infection&#xD;
&#xD;
          7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time&#xD;
             of the procedure&#xD;
&#xD;
          8. Known/suspected gynecological malignancy within the past 5 years&#xD;
&#xD;
          9. Known clotting defects or bleeding disorders&#xD;
&#xD;
         10. Untreated/unevaluated cervical dyskaryosis (except CIN I)&#xD;
&#xD;
         11. Known or suspected abdominal/pelvic cancer&#xD;
&#xD;
         12. Prior uterine surgery (except lower segment caesarean section) that interrupts the&#xD;
             integrity of the uterine wall (e.g., myomectomy or classical cesarean section)&#xD;
&#xD;
         13. Previous endometrial ablation procedure&#xD;
&#xD;
         14. Currently on medications that could thin the myometrial muscle, such as long-term&#xD;
             steroid use (except inhaler or nasal therapy for asthma)&#xD;
&#xD;
         15. Currently on anticoagulants&#xD;
&#xD;
         16. Abnormal shaped uterine cavity as confirmed by transvaginal ultrasound scan +/-&#xD;
             hysteroscopy - specifically:&#xD;
&#xD;
               -  Septate or bicornuate uterus or other congenital malformation of the uterine&#xD;
                  cavity&#xD;
&#xD;
               -  Submucosal fibroids (grade 0-2) which protrude &gt;1cm into the uterine cavity&#xD;
&#xD;
               -  Polyps &gt; 2cm in maximum diameter&#xD;
&#xD;
               -  Intramural or subserosal fibroid greater than 3 cm&#xD;
&#xD;
         17. Presence of an intrauterine device (IUD) which the subject unwilling to have removed&#xD;
             at the time of the operative visit&#xD;
&#xD;
         18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).&#xD;
&#xD;
         19. Subject not currently on hormonal birth control therapy and unwilling to use a&#xD;
             non-hormonal birth control post-ablation.&#xD;
&#xD;
         20. Subject wanting concomitant hysteroscopic sterilization.&#xD;
&#xD;
         21. Subject who is within 6-weeks post-partum.&#xD;
&#xD;
         22. Any general health condition which, in the opinion of the Investigator, could&#xD;
             represent an increased risk for the subject&#xD;
&#xD;
         23. Any subject who is currently participating or considers future participation in any&#xD;
             other&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Clark, MB ChB, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham Women's NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justin Clark, MB ChB, MD</last_name>
    <phone>0044 1216074712</phone>
    <email>t.j.clark@doctors.org.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helen Stevenson, MB ChB</last_name>
    <phone>0044 121472177</phone>
    <email>helen_stevenson@bwnft.nhs.uk</email>
  </overall_contact_backup>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=shaw+r+and+1998+and+menorrhagia</url>
    <description>link to pubmed</description>
  </link>
  <reference>
    <citation>Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol. 1998 Nov;105(11):1155-9. doi: 10.1111/j.1471-0528.1998.tb09968.x.</citation>
    <PMID>9853763</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Birmingham Women's NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Mr.Justin Clark</investigator_full_name>
    <investigator_title>Consultant Gynaecologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971189
org study id: Birmingham WHC
nct id: NCT02971189
lead sponsor: 
has dmc: Yes
A prospective, single-arm, non-randomised study to evaluate the Librata device performance
      and acute safety in performing global endometrial ablation in pre-menopausal women with heavy
      menstrual bleeding.
4 clinical sits around the UK aim to recruit 40 women into a study to assess the primary
      objective of procedure success using the Librata endometrial ablation device, as defined as
      device success (completion of treatment cycles according to device specifications) and no
      occurrence of intra-procedural complications.

      The investigators will also assess the secondary objectives of:

        1. Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram

        2. Rate of serious adverse device effects through to day 30 post-operatively

        3. Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6
           and 12 months

        4. Rates of patient satisfaction at 6 and 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.
time frame: Day of surgery
measure: rates of bleeding as measured by menstrual pictogram
time frame: 12 months
measure: rate of serious adverse device effects
time frame: day 30 post-operatively
measure: Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy
time frame: 12 months
measure: Rates of patient satisfaction
time frame: 12 months
arm group label: Librata endometrial ablation
arm group type: Other
description: Librata thermal balloon endometrial ablation treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.
intervention type: Device
intervention name: Librata Endometrial Ablation
description: The treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.
arm group label: Librata endometrial ablation
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Justin Clark, MB ChB, MD
role: Principal Investigator
affiliation: Birmingham Women's NHS Foundation Trust
last name: Justin Clark, MB ChB, MD
phone: 0044 1216074712
email: t.j.clark@doctors.org.uk
last name: Helen Stevenson, MB ChB
phone: 0044 121472177
email: helen_stevenson@bwnft.nhs.uk
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=shaw+r+and+1998+and+menorrhagia
description: link to pubmed
citation: Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol. 1998 Nov;105(11):1155-9. doi: 10.1111/j.1471-0528.1998.tb09968.x.
PMID: 9853763
responsible party type: Principal Investigator
investigator affiliation: Birmingham Women's NHS Foundation Trust
investigator full name: Mr.Justin Clark
investigator title: Consultant Gynaecologist
mesh term: Menorrhagia
sharing ipd: No