- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03725306
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss (LEADER)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Barbara Cox
- Phone Number: 6175964183
- Email: bco@lina-medical.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Librata
Librata Endometrial Ablation Device
|
Hyperthermic endomyometrial treatment via Librata catheter and balloon device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Menstrual Bleeding
Time Frame: 12 months post-treatment
|
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.
|
12 months post-treatment
|
Incidence of serious adverse events (SAEs).
Time Frame: 12 months post-treatment
|
The primary safety endpoint
|
12 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Quality of Life
Time Frame: 12 months
|
Responses from quality of life questionnaires
|
12 months
|
Procedure Time
Time Frame: During procedure
|
Librata ablation procedure time
|
During procedure
|
Menstrual Blood Loss
Time Frame: 3, 6, 12, 24 and 36 months
|
Menstrual blood loss assessment
|
3, 6, 12, 24 and 36 months
|
Rates of Re-Intervention
Time Frame: Month 12
|
Rate of repeat ablation and/or hysterectomy surgery
|
Month 12
|
Incidence of Unanticipated Adverse Device Effects (UADEs)
Time Frame: Month 12
|
Month 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claude Fortin, MD, LaSalle, QC
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEADER NA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Birmingham Women's NHS Foundation TrustUnknown