Fibroid Ablation Study - Large Fibroids (FAST-L)

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