Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System

Exclusion Criteria

• •Known or suspected endometrial cancer or pre-malignant change of the endometrium
• •Untreated cervical dysplasia
• •Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
• •Uterine myomas \> or = to 3 cm in diameter
• •Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
• •History of classical (not low transverse incision) cesarean section
• •Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
• •Intrauterine device (IUD) in place
• •Other medical conditions could be exclusionary upon evaluation for study treatment