Investigational device changes; adequate enrollment achieved

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

Inclusion Criteria:

• 28 years of age or older
• Regular, consistent menstrual cycles
• History of excessive bleeding
• One Menstrual Pictogram score ≥ 120 during a one-month screening period
• Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
• Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc
• At least one fibroid must indent the endometrium
• Subject is not at material risk for pregnancy.
• Subject is willing to maintain use or non-use of hormonal contraception
• Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents

Exclusion Criteria:

• Subserosal fibroids with bulk symptoms
• Presence of type 0 intracavitary fibroids
• Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
• Any fibroid that obstructs access of the VizAblate probe
• Postmenopausal by history
• Desire for current or future fertility
• Hemoglobin < 6 g/dl
• Pregnancy
• Evidence of disorders of hemostasis
• Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM)
• Short-term use of hormonal medication for management of bleeding
• Evidence for current cervical dysplasia
• Endometrial hyperplasia
• Confirmed abdominal / pelvic malignancy within the previous five years
• Active pelvic infection
• Clinically significant adenomyosis
• Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months
• Current use of anticoagulant therapy
• Need for emergency surgery to treat fibroid symptoms
• Concomitant intrauterine polyps > 1.0 cm
• Contraindication to MRI
• Renal insufficiency
• Uncontrolled hypertension lasting 2 years or more
• One or more treatable fibroids that are calcified
• Chronic pelvic pain
• Presence of an extrauterine pelvic mass
• Presence of a tubal implant for sterilization
• Previous pelvic irradiation
• Endometrial cavity length < 4.5 cm