High Intensity Focused Ultrasound in Uterine Myoma
Not Applicable
Completed
- Conditions
- Uterine Leiomyoma
- Interventions
- Device: HIFU
- Registration Number
- NCT03328260
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment HIFU -
- Primary Outcome Measures
Name Time Method Non perfused volume treatment day Non perfused volume in myoma immediately after ablation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam Si, Gyenggi DO, Korea, Republic of