NCT03328260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

October 29, 2017

Last Update Submit

January 1, 2020

Conditions

Uterine Leiomyoma

Outcome Measures

Primary Outcomes (1)

  • Non perfused volume

    Non perfused volume in myoma immediately after ablation

    treatment day

Study Arms (1)

Treatment

EXPERIMENTAL
Device: HIFU

Interventions

HIFUDEVICE

Transvaginal high intensity focused ultrasound to ablate uterine myoma

Treatment

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premenopausal (FSH \< 40 IU/L)
  • Symptomatic uterine fibroids
  • Willing to contracept during study period

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyenggi DO, 463707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33259999DERIVED

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 1, 2017

Study Start

December 12, 2017

Primary Completion

August 31, 2018

Study Completion

June 30, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)