Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

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