China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

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