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

NCT ID: NCT02914704

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Uterine Fibroids; Adenomyosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients treated with MRI-HIFU

Group Type: EXPERIMENTAL

MRI-HIFU

Intervention Type: DEVICE

Treatment of uterine fibroids with MRI-HIFU

Interventions

MRI-HIFU

Treatment of uterine fibroids with MRI-HIFU

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsi M Joronen, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Kirsi M Joronen, PhD

Role: CONTACT

kirsi.joronen@tyks.fi

Facility Contacts

Kirsi M Joronen, MD PhD

Role: primary

kirsi.joronen@tyks.fi

+35823130561

Other Identifiers

GYN-HIFU

Identifier Type: -

Identifier Source: org_study_id