Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

Inclusion Criteria:

* Women, age between 18 and 50 years
* Ethnicity has a match with the intended profile for the site
* Weight \< 140kg or 310lbs
* Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level \< 40 IU/L
* Willing and able to attend all study visits
* Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
* Willing and able to use reliable contraception methods
* Uterine size \< 24 weeks
* Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
* MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
* Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):

  1. Total planned ablation volume of all fibroids should not exceed 250 ml and
  2. No more than 5 fibroids should be planned for ablation and
  3. Dominant fibroid (diameter) is greater than or equal to 3 cm and
  4. Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous
* Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months.
* Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml

Exclusion Criteria:

* Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
* Desire for future pregnancy
* Significant systemic disease even if controlled
* Positive pregnancy test
* Hematocrit \< 25%
* Extensive scarring along anterior lower abdominal wall (\>50% of area)
* Surgical clips in the potential path of the HIFU beam
* MRI contraindicated
* MRI contrast agent contraindicated (including renal insufficiency)
* Calcifications around or throughout uterine tissues that may affect treatment
* Communication barrier
* Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
* Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
* Menses lasting \> 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
* Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:

  1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
  2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
  3. Depo Provera or equivalent: less than 6 months prior to MBL measurement