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