A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

Exclusion Criteria

• •Pregnant or has a desire to conceive
• •Endometrial hyperplasia as confirmed by histology
• •Active endometritis
• •Active pelvic inflammatory disease
• •Active sexually transmitted disease (STD)
• •Presence of bacteremia, sepsis, or other active systemic infection
• •Active infection of the genitals, vagina, cervix, or uterus
• •Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
• •Known clotting defects or bleeding disorders
• •Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards.
• •Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section).
• •Previous low transverse cesarean section where the myometrial wall thickness is insufficient
• •Previous endometrial ablation procedure
• •Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment
• •Presence of an implantable contraceptive device
• •Currently on medications that could thin the myometrial muscle
• •Currently on anticoagulants
• •Abnormal or obstructed cavity
• •Currently using an intrauterine device (IUD) and unwilling to remove the IUD
• •Post-partum ≤ 6-months
• •Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
• •Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements