Treatment of Benign Uterine Disorders Using High Intensit... | NCT02914704

Studies
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

NCT02914704

Sponsor

Turku University Hospital

Status

Unknown status

Last Update Posted

Apr 29, 2019Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Uterine Fibroids
Adenomyosis

Interventions

MRI-HIFU

Countries

Finland

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 5, 2016

First Submission Date that Met QC Criteria

Sep 22, 2016

First Posted Date

Sep 26, 2016Estimated

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

Apr 26, 2019

Last Update Posted Date

Apr 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.

Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.

Detailed Description

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with MRI-HIFU	Experimental		Device: MRI-HIFU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI-HIFU	Device	Treatment of uterine fibroids with MRI-HIFU	Patients treated with MRI-HIFU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score		12 months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI < 35
Premenopausal
Uterine size <20 gw
Willingness to participate to the research
Uterine fibroids with typical symptoms
Maximum of 4 treated fibroids
Dominant fibroid >2.5cm
>50% of the fibroid is treatable

Exclusion criteria

Unspecified pelvic tumours or ovarian masses, PID
Major corrective surgery to uterus (simple myomectomy excluded)
Major uterine anomalies
Unability to calculate the volume of uterine fibroids
Marked uterine calcification
Marked scarring of the lower abdomen
Suspicion of malignancy
Marked general health problem contraindicating MRI
Claustrophobia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kirsi M Joronen, PhD	Contact			kirsi.joronen@tyks.fi

Overall Officials

Name	Affiliation	Role
Kirsi M Joronen, PhD	Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital	Recruiting	Turku		20521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42294814	Derived	Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Lehtonen I, Blanco Sequeiros R, Perheentupa A, Joronen K. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy of uterine fibroids effectively reduces both bleeding and bulk symptoms-A prospective single-center 12-month follow-up study. Acta Obstet Gynecol Scand. 2026 Jun 15. doi: 10.1111/aogs.70268. Online ahead of print.

ID	Term
D007889	Leiomyoma
D062788	Adenomyosis

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms