High Intensity Focused Ultrasound in Uterine Myoma

January 1, 2020 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyenggi DO
      • Seongnam Si, Gyenggi DO, Korea, Republic of, 463707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non perfused volume
Time Frame: treatment day
Non perfused volume in myoma immediately after ablation
treatment day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

ALPINION Medical Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APM-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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