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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02914704
• Other study ID #: GYN-HIFU
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Turku University Hospital
• Contact: Kirsi M Joronen, PhD
• Email: kirsi.joronen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Uterine Diseases
• Uterine Fibroids

Intervention

Device:
• MRI-HIFU
Treatment of uterine fibroids with MRI-HIFU

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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