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Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom (LEADERUK)

Primary Purpose

Heavy Menstrual Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Librata Endometrial Ablation
Sponsored by
Birmingham Women's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Refractory heavy menstrual bleeding with no definable organic cause
  2. Female subject from (and including) age 25 to 50 years
  3. Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).
  4. A minimum menstrual blood loss of

    • Menstrual Pictogram (MP) score of ≥150 for 3 consecutive months prior to study enrollment; OR,
    • MP score ≥150 for one month for women who either had:

      • at least 3 prior months documented failed medical therapy; or
      • a contraindication to medical therapy; or
      • refused medical therapy
  5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
  6. Not pregnant and no desire to conceive at any time
  7. Subject agrees to use a reliable form of contraception. If a hormonal birth control method is used, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through their study participation.
  8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
  9. Subject agrees to follow-up schedule and data collection requirements
  10. Subject is literate or demonstrates an understanding on how to collect menstrual blood loss products, and use of the Menstrual Pictogram (MP) diary

Exclusion Criteria:

Participants who have or meet any of the following exclusion criteria will not be enrolled in the Study:

  1. Pregnancy or subject with a desire to become pregnant
  2. Endometrial hyperplasia as confirmed by histology
  3. Presence of active endometritis
  4. Active pelvic inflammatory disease
  5. Active sexually transmitted disease (STD), at the time of ablation.

    • Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.
  6. Presence of bacteraemia, sepsis, or other active systemic infection
  7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
  8. Known/suspected gynecological malignancy within the past 5 years
  9. Known clotting defects or bleeding disorders
  10. Untreated/unevaluated cervical dyskaryosis (except CIN I)
  11. Known or suspected abdominal/pelvic cancer
  12. Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
  13. Previous endometrial ablation procedure
  14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
  15. Currently on anticoagulants
  16. Abnormal shaped uterine cavity as confirmed by transvaginal ultrasound scan +/- hysteroscopy - specifically:

    • Septate or bicornuate uterus or other congenital malformation of the uterine cavity
    • Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity
    • Polyps > 2cm in maximum diameter
    • Intramural or subserosal fibroid greater than 3 cm
  17. Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
  18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).
  19. Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation.
  20. Subject wanting concomitant hysteroscopic sterilization.
  21. Subject who is within 6-weeks post-partum.
  22. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
  23. Any subject who is currently participating or considers future participation in any other

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Librata endometrial ablation

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.

    Secondary Outcome Measures

    rates of bleeding as measured by menstrual pictogram
    rate of serious adverse device effects
    Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy
    Rates of patient satisfaction

    Full Information

    First Posted
    November 19, 2016
    Last Updated
    November 21, 2016
    Sponsor
    Birmingham Women's NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02971189
    Brief Title
    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom
    Acronym
    LEADERUK
    Official Title
    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Birmingham Women's NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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: Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram Rate of serious adverse device effects through to day 30 post-operatively Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6 and 12 months Rates of patient satisfaction at 6 and 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heavy Menstrual Bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Librata endometrial ablation
    Arm Type
    Other
    Arm 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(s)
    Librata Endometrial Ablation
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    rates of bleeding as measured by menstrual pictogram
    Time Frame
    12 months
    Title
    rate of serious adverse device effects
    Time Frame
    day 30 post-operatively
    Title
    Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy
    Time Frame
    12 months
    Title
    Rates of patient satisfaction
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Refractory heavy menstrual bleeding with no definable organic cause Female subject from (and including) age 25 to 50 years Uterine sound measurement between 6.0 to 10.0cm (external os to fundus). A minimum menstrual blood loss of Menstrual Pictogram (MP) score of ≥150 for 3 consecutive months prior to study enrollment; OR, MP score ≥150 for one month for women who either had: at least 3 prior months documented failed medical therapy; or a contraindication to medical therapy; or refused medical therapy Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L Not pregnant and no desire to conceive at any time Subject agrees to use a reliable form of contraception. If a hormonal birth control method is used, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through their study participation. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC Subject agrees to follow-up schedule and data collection requirements Subject is literate or demonstrates an understanding on how to collect menstrual blood loss products, and use of the Menstrual Pictogram (MP) diary Exclusion Criteria: Participants who have or meet any of the following exclusion criteria will not be enrolled in the Study: Pregnancy or subject with a desire to become pregnant Endometrial hyperplasia as confirmed by histology Presence of active endometritis Active pelvic inflammatory disease Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment. Presence of bacteraemia, sepsis, or other active systemic infection Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure Known/suspected gynecological malignancy within the past 5 years Known clotting defects or bleeding disorders Untreated/unevaluated cervical dyskaryosis (except CIN I) Known or suspected abdominal/pelvic cancer Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section) Previous endometrial ablation procedure Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma) Currently on anticoagulants Abnormal shaped uterine cavity as confirmed by transvaginal ultrasound scan +/- hysteroscopy - specifically: Septate or bicornuate uterus or other congenital malformation of the uterine cavity Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity Polyps > 2cm in maximum diameter Intramural or subserosal fibroid greater than 3 cm Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit Presence of an implantable contraceptive device (e.g. Essure or Adiana). Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation. Subject wanting concomitant hysteroscopic sterilization. Subject who is within 6-weeks post-partum. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject Any subject who is currently participating or considers future participation in any other
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Justin Clark, MB ChB, MD
    Phone
    0044 1216074712
    Email
    t.j.clark@doctors.org.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Helen Stevenson, MB ChB
    Phone
    0044 121472177
    Email
    helen_stevenson@bwnft.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Justin Clark, MB ChB, MD
    Organizational Affiliation
    Birmingham Women's NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9853763
    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.
    Results Reference
    background
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/?term=shaw+r+and+1998+and+menorrhagia
    Description
    link to pubmed

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    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom

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