Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Inclusion Criteria:

• Pre-menopausal
• Regular, consistent menstrual cycles
• Serum progesterone > 6 ng/ml (19 nmol/L)
• 2 months history of PBLAC score of 150-500
• Maximum of 4 type I, type II, or intramural fibroids
• Patient is at low risk for cervical cancer
• Hemoglobin > 6 g/dl
• Not at risk for pregnancy
• No desire for future fertility
• Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
• Willing to sign a consent form

Exclusion Criteria:

• Subserosal fibroids.
• Any fibroid that obstructs access to the endometrial cavity
• FSH > 20 IU/L
• Pregnancy
• Evidence of disorders of hemostasis
• Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
• SERMS/SPRMS within the last 6 months
• Current use of any IUD or use of Mirena IUS within the last 3 months
• Gynecological malignancy or hyperplasia
• Known/suspected abdominal/pelvic cancer
• Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
• Adenomyosis
• Previous surgical or ablative treatment for fibroids or menorrhagia
• Previous uterine artery embolization or occlusion
• Patient on anti-coagulation therapy
• Needing emergency surgery to treat fibroid symptoms
• Concomitant intrauterine polyps.
• Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data
• Contraindication to MRI
• Allergy to contrast media
• Mild renal insufficiency or worse
• Known renal disease
• Uncontrolled hypertension lasting 2 years or more
• Diabetes
• Uterine size > 10 weeks or 10 cm from ectocervix to fundus.