NCT03328260CompletedNot Applicable
Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
Seoul National University Hospital2 sites in 1 country34 target enrollmentStarted: December 12, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Non perfused volume
Study Overview
Brief Summary
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Non perfused volume
Time Frame: treatment day
Non perfused volume in myoma immediately after ablation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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