Inclusion Criteria:

- Women, age between 18 and 55 years

- Weight < 140 kg

- Pre- or peri-menopausal

- Uterine size < 24 weeks

- Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low
Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or
Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue

- Fibroids selected for treatment meeting the following criteria:

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. Fibroids which are completely non-enhancing under Magnetic Resonance (MR)
contrast agent should not be treated as the identification of treated volume
becomes ambiguous

5. Highly perfused or brighter than myometrium in T2-weighted MRI (according to the
T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be
treated

- MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid
volume can be treated

- Willing and able to attend all study visits

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 direct path of the HIFU beam

- MRI contraindicated

- MRI contrast agent contraindicated

- Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements
are not feasible)

- Calcifications around or throughout uterine tissues

- Communication barrier

- Suspected malignancy