Back to resultsTreatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Primary Purpose
Uterine Fibroids, Adenomyosis
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
MRI-HIFU
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
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
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients treated with MRI-HIFU
Arm Description
Outcomes
Primary Outcome Measures
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Secondary Outcome Measures
Full Information
NCT ID
NCT02914704
First Posted
January 5, 2016
Last Updated
April 26, 2019
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02914704
Brief Title
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Official Title
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Adenomyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with MRI-HIFU
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI-HIFU
Intervention Description
Treatment of uterine fibroids with MRI-HIFU
Primary Outcome Measure Information:
Title
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Time Frame
12 months after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsi M Joronen, PhD
Email
kirsi.joronen@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi M Joronen, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsi M Joronen, MD PhD
Phone
+35823130561
Email
kirsi.joronen@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
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