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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

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

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Device: HIFU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Treatment Device: HIFU
Transvaginal high intensity focused ultrasound to ablate uterine myoma




Primary Outcome Measures :
  1. Non perfused volume [ Time Frame: treatment day ]
    Non perfused volume in myoma immediately after ablation



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328260


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
Sponsors and Collaborators
Seoul National University Hospital
ALPINION Medical Systems
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03328260    
Other Study ID Numbers: APM-05
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases