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Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss (LEADER)

Primary Purpose

Menorrhagia, Heavy Menstrual Bleeding

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Librata
Sponsored by
LiNA Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Heavy Menstrual Bleeding, Endometrial Ablation

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Candidates for this study must meet ALL of the following criteria:

  • Refractory menorrhagia with no organic cause
  • Female subject from (and including) age 25 to 50 years
  • Uterine sound measurement ≥6.0 cm to ≤ 10.0cm (external os to fundus).

  • A minimum menstrual blood loss

    • for subjects not using medical therapy, a Menstrual Pictogram(MP) score of ≥150 for two baseline cycles within three months prior to treatment OR

    • MP score ≥150 for one month for women who either had

      • at least 3 prior months documented failed medical therapy; or
      • had 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 visits and data collection requirements
  • Subject who is literate or demonstrates an understanding on how to use the Menstrual Pictogram (MP) diary 4.1.1. EXCLUSION CRITERIA

To be enrolled, candidates should NOT meet any exclusion criterion:

  • 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.

    o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.

  • Presence of bacteremia, 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 dysplasia (except CIN I)
  • Known/suspected abdominal/pelvic cancer
  • Prior uterine surgery (except low segment cesarean 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 or obstructed cavity as confirmed by transvaginal ultrasound +/- hysteroscopy - specifically:

    1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity
    2. Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity
    3. Polyps >2 cm in maximum diameter
    4. Any intramural myoma > 3 cm or which distorts the uterine cavity
  • Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
  • Presence of an implanted 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 in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Librata

    Arm Description

    Librata Endometrial Ablation Device

    Outcomes

    Primary Outcome Measures

    Change in Menstrual Bleeding
    Clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary.
    Incidence of serious adverse events (SAEs).
    The primary safety endpoint

    Secondary Outcome Measures

    Changes in Quality of Life
    Responses from quality of life questionnaires
    Procedure Time
    Librata ablation procedure time
    Menstrual Blood Loss
    Menstrual blood loss assessment
    Rates of Re-Intervention
    Rate of repeat ablation and/or hysterectomy surgery
    Incidence of Unanticipated Adverse Device Effects (UADEs)

    Full Information

    First Posted
    October 29, 2018
    Last Updated
    November 5, 2018
    Sponsor
    LiNA Medical
    Collaborators
    Syntactx, West Virginia University, Pathology Laboratory for Translational Medicine, Infinite Clinical Research, S.A. de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03725306
    Brief Title
    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
    Acronym
    LEADER
    Official Title
    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LiNA Medical
    Collaborators
    Syntactx, West Virginia University, Pathology Laboratory for Translational Medicine, Infinite Clinical Research, S.A. de C.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre-menopausal women with menorrhagia due to benign causes for whom childbearing is complete.
    Detailed Description
    Menorrhagia is ovulatory (cyclic), heavy bleeding, that should be treated when it interferes with quality of life or causes anemia. It is a common problem and it is estimated that 5% of women aged 30 to 49 seek referral for evaluation and treatment. No structural cause is found in the majority of women with menorrhagia and treatment intends to reduce blood loss and improve quality of life. First line treatment is medical therapy with hormonal therapy using either the combined contraceptive pill or the levonorgestrel-releasing intrauterine system. These treatments are not suitable for all women and indeed some women may not find them acceptable. For these women, surgical management is then offered with either endometrial ablation or hysterectomy. The primary objective of this study is to evaluate the clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary at 12 months post-treatment. Additionally, a secondary objective is to determine the primary safety incidence of serious adverse events (SAEs) by 12 months. The study is designed as a prospective, multi-center, single-arm, controlled trial to demonstrate that the percentage of subjects with reduction in menstrual bleeding at 12 months is significantly greater than 66%. A total of 200 subjects will be enrolled. The study population will include pre-menopausal women, aged 25-50 with a history of menorrhagia due to benign causes for whom childbearing is complete.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Objective Performance Criterion
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Librata
    Arm Type
    Experimental
    Arm Description
    Librata Endometrial Ablation Device
    Intervention Type
    Device
    Intervention Name(s)
    Librata
    Intervention Description
    Hyperthermic endomyometrial treatment via Librata catheter and balloon device
    Primary Outcome Measure Information:
    Title
    Change in Menstrual Bleeding
    Description
    Clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary.
    Time Frame
    12 months post-treatment
    Title
    Incidence of serious adverse events (SAEs).
    Description
    The primary safety endpoint
    Time Frame
    12 months post-treatment
    Secondary Outcome Measure Information:
    Title
    Changes in Quality of Life
    Description
    Responses from quality of life questionnaires
    Time Frame
    12 months
    Title
    Procedure Time
    Description
    Librata ablation procedure time
    Time Frame
    During procedure
    Title
    Menstrual Blood Loss
    Description
    Menstrual blood loss assessment
    Time Frame
    3, 6, 12, 24 and 36 months
    Title
    Rates of Re-Intervention
    Description
    Rate of repeat ablation and/or hysterectomy surgery
    Time Frame
    Month 12
    Title
    Incidence of Unanticipated Adverse Device Effects (UADEs)
    Time Frame
    Month 12

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pre-menopausal women for whom childbearing is complete
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Candidates for this study must meet ALL of the following criteria: Refractory menorrhagia with no organic cause Female subject from (and including) age 25 to 50 years Uterine sound measurement ≥6.0 cm to ≤ 10.0cm (external os to fundus). A minimum menstrual blood loss for subjects not using medical therapy, a Menstrual Pictogram(MP) score of ≥150 for two baseline cycles within three months prior to treatment OR MP score ≥150 for one month for women who either had at least 3 prior months documented failed medical therapy; or had 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 visits and data collection requirements Subject who is literate or demonstrates an understanding on how to use the Menstrual Pictogram (MP) diary 4.1.1. EXCLUSION CRITERIA To be enrolled, candidates should NOT meet any exclusion criterion: 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. o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment. Presence of bacteremia, 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 dysplasia (except CIN I) Known/suspected abdominal/pelvic cancer Prior uterine surgery (except low segment cesarean 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 or obstructed cavity as confirmed by transvaginal ultrasound +/- 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 >2 cm in maximum diameter Any intramural myoma > 3 cm or which distorts the uterine cavity Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit Presence of an implanted 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 in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barbara Cox
    Phone
    6175964183
    Email
    bco@lina-medical.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claude Fortin, MD
    Organizational Affiliation
    LaSalle, QC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

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