Fibroid Ablation Study

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

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