Heavy Menstrual Bleeding, Menorrhagia
Conditions
Keywords
Heavy Menstrual Bleeding, Endometrial Ablation
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.
Interventions
DEVICELibrata
Hyperthermic endomyometrial treatment via Librata catheter and balloon device
Sponsors
Syntactx
West Virginia University, Pathology Laboratory for Translational Medicine
Infinite Clinical Research, S.A. de C.V.
LiNA Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Objective Performance Criterion
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion 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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menstrual Bleeding | 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. |
| Incidence of serious adverse events (SAEs). | 12 months post-treatment | The primary safety endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of Life | 12 months | Responses from quality of life questionnaires |
| Procedure Time | During procedure | Librata ablation procedure time |
| Menstrual Blood Loss | 3, 6, 12, 24 and 36 months | Menstrual blood loss assessment |
| Rates of Re-Intervention | Month 12 | Rate of repeat ablation and/or hysterectomy surgery |
| Incidence of Unanticipated Adverse Device Effects (UADEs) | Month 12 | — |
Contacts
Primary ContactBarbara Cox
Outcome results
None listed