Fibroid Ablation Study - Large Fibroids

Inclusion Criteria: * 28 years of age or older * Consistent menstrual cycles * History of excessive bleeding for at least 3 months * Baseline UFS-QOL Symptom severity score ≥ 20 * At least one target fibroid having a maximum diameter \> 5cm and ≤ 10 cm * Not at material risk for pregnancy * Willingness to participate, adhere to follow-up requirements, and sign the informed consent form * Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents * Menstrual Pictogram score ≥ 120 during a one-month screening period. Exclusion Criteria: * Presence of type 0 intracavitary fibroids * Target fibroid \> 10cm in maximum diameter * Abnormality of the endometrial cavity that obstructs access of the treatment device * Postmenopausal * Desire for current or future fertility * Hemoglobin \< 6 g/dl * Evidence of disorders of hemostasis * Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening * Evidence for current cervical dysplasia (CIN II or greater) * Endometrial hyperplasia * Confirmed abdominal / pelvic malignancy within previous five years * Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia * Clinically significant adenomyosis * Previous uterine artery embolization * Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening * Current use of anticoagulant therapy * Major medical or psychiatric illness affecting general health or ability to adhere to follow-up * Contraindication to MRI * Renal insufficiency * Uncontrolled hypertension lasting 2 years or more * Calcified fibroids * Presence of extrauterine pelvic mass * Presence of tubal implant for sterilization * Previous pelvic irradiation * Endometrial cavity length \< 4.5 cm