Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom

Exclusion Criteria

• •1. Pregnancy or subject with a desire to become pregnant
• •2. Endometrial hyperplasia as confirmed by histology
• •3. Presence of active endometritis
• •4. Active pelvic inflammatory disease
• •5. 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.
• •6. Presence of bacteraemia, sepsis, or other active systemic infection
• •7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
• •8. Known/suspected gynecological malignancy within the past 5 years
• •9. Known clotting defects or bleeding disorders
• •10. Untreated/unevaluated cervical dyskaryosis (except CIN I)
• •11. Known or suspected abdominal/pelvic cancer
• •12. Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
• •13. Previous endometrial ablation procedure
• •14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
• •15. Currently on anticoagulants
• •16. Abnormal shaped uterine cavity as confirmed by transvaginal ultrasound scan +/- 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 \> 2cm in maximum diameter
• •* Intramural or subserosal fibroid greater than 3 cm
• •17. Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
• •18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).
• •19. Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation.
• •20. Subject wanting concomitant hysteroscopic sterilization.
• •21. Subject who is within 6-weeks post-partum.
• •22. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
• •23. Any subject who is currently participating or considers future participation in any other