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High Intensity Focused Ultrasound in Uterine Myoma

Primary Purpose

Uterine Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HIFU
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Non perfused volume
Non perfused volume in myoma immediately after ablation

Secondary Outcome Measures

Full Information

First Posted
October 29, 2017
Last Updated
January 1, 2020
Sponsor
Seoul National University Hospital
Collaborators
ALPINION Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT03328260
Brief Title
High Intensity Focused Ultrasound in Uterine Myoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
ALPINION Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HIFU
Intervention Description
Transvaginal high intensity focused ultrasound to ablate uterine myoma
Primary Outcome Measure Information:
Title
Non perfused volume
Description
Non perfused volume in myoma immediately after ablation
Time Frame
treatment day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam Si
State/Province
Gyenggi DO
ZIP/Postal Code
463707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33259999
Citation
Lee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049. Epub 2020 Nov 17.
Results Reference
derived

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High Intensity Focused Ultrasound in Uterine Myoma

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