Status:
COMPLETED
High Intensity Focused Ultrasound in Uterine Myoma
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
ALPINION Medical Systems
Conditions:
Uterine Leiomyoma
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
Eligibility Criteria
Inclusion
- Premenopausal (FSH \< 40 IU/L)
- Symptomatic uterine fibroids
- Willing to contracept during study period
Exclusion
- 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
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03328260
Start Date
December 12 2017
End Date
June 30 2019
Last Update
January 3 2020
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, South Korea, 463707