Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

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.
• 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