The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment
of uterine fibroids in a Chinese population.
Device: MR-HIFU uterine fibroid treatment
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Full eligibility criteria for NCT01588899
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
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:
Total planned ablation volume of all fibroids should not exceed 250 ml, and
No more than 5 fibroids should be planned for ablation, and
Dominant fibroid (diameter) is greater than or equal to 3 cm, and
Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
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
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