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High Intensity Focused Ultrasound in Uterine Myoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03328260
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
ALPINION Medical Systems
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE October 29, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE December 12, 2017
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2017)
Non perfused volume [ Time Frame: treatment day ]
Non perfused volume in myoma immediately after ablation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Focused Ultrasound in Uterine Myoma
Official Title  ICMJE Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
Brief Summary Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Leiomyoma
Intervention  ICMJE Device: HIFU
Transvaginal high intensity focused ultrasound to ablate uterine myoma
Study Arms  ICMJE Experimental: Treatment
Intervention: Device: HIFU
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03328260
Other Study ID Numbers  ICMJE APM-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE ALPINION Medical Systems
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP