High Intensity Focused Ultrasound in Uterine Myoma

Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma

Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma

Inclusion Criteria:

• Premenopausal (FSH < 40 IU/L)
• Symptomatic uterine fibroids
• Willing to contracept during study period

Exclusion Criteria:

• Pregnant or willing to be pregnant in future
• Cancer in female reproductive organ is suspected or diagnosed
• Inflammation in female reproductive organ
• Poorly controlled systemic disease
• Hematocrit < 25%
• Glomerular filtration rate(GFR) <= 30ml/min
• Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
• Cannot lie down
• Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
• Cannot count the number or measure volume of leiomyoma using MRI
• Leiomyomas are inadequate (location, volume, number) for intervention
• Diameter of leiomyoma is over 5 cm
• Leiomyoma is not enhanced
• Lactating women
• Cannot communicate properly
• Participating or have participated in other trials within 30 days