High Intensity Focused Ultrasound in Uterine Myoma

Seoul National University

Status: Completed

Conditions: Uterine Leiomyoma

Treatments: Device: HIFU

Study type: Interventional

Funder types: Other

Identifiers

NCT03328260

APM-05

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: HIFU