High Intensity Focused Ultrasound in Uterine Myoma

Uterine Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328260
• Other study ID #: APM-05
• Status: Completed
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 30, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 ? myolysis, ? myomectomy within 1 year, ? 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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

Device:
• HIFU
Transvaginal high intensity focused ultrasound to ablate uterine myoma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam Si	Gyenggi DO

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	ALPINION Medical Systems

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non perfused volume	Non perfused volume in myoma immediately after ablation	treatment day