Fibroid Ablation Study - Large Fibroids

Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine 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