High Intensity Focused Ultrasound in Uterine Myoma | NCT03328260

Studies
High Intensity Focused Ultrasound in Uterine Myoma

NCT03328260

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 3, 2020Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Uterine Leiomyoma

Interventions

HIFU

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2017Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Oct 29, 2017

First Submission Date that Met QC Criteria

Oct 29, 2017

First Posted Date

Nov 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2020

Last Update Posted Date

Jan 3, 2020Actual

Name	Class
ALPINION Medical Systems	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: HIFU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIFU	Device	Transvaginal high intensity focused ultrasound to ablate uterine myoma	Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyenggi DO	463707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33259999	Derived	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.

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms