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Search / Trial NCT02914704

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

Launched by TURKU UNIVERSITY HOSPITAL · Sep 22, 2016

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called MRI-guided high intensity focused ultrasound (MRI-HIFU) for women with benign uterine conditions like uterine fibroids and adenomyosis. The goal is to learn more about how this treatment affects the body, particularly regarding fertility, and to see how effective it is in relieving symptoms. Women who are experiencing significant symptoms from these conditions and meet certain eligibility criteria, such as being premenopausal with a body mass index (BMI) under 35, may be able to participate.

If you join the study, you can expect to undergo the MRI-HIFU treatment, and your symptoms will be checked at various times—like 3, 6, and 12 months after the treatment—using a questionnaire about your quality of life. Additionally, researchers will collect samples of blood, urine, and tissue to study how your body responds to the treatment. This trial is particularly important as it is the first of its kind in Finland, and it aims to improve how patients are selected for treatment and how effective the treatment is overall. Your participation could contribute valuable information that may help other women in the future.

Gender

FEMALE

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

About Turku University Hospital

Turku University Hospital (TYKS) is a leading academic medical center located in Turku, Finland, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a key institution within the University of Turku, TYKS integrates cutting-edge medical education with state-of-the-art clinical services, offering a broad spectrum of specialized care. The hospital actively participates in clinical trials, facilitating the translation of scientific discoveries into practical treatments, and enhancing patient outcomes. With a multidisciplinary approach and a focus on collaboration, TYKS aims to contribute significantly to the global medical community through its rigorous research initiatives and commitment to patient-centered care.

Locations

Turku, , Finland

Patients applied

0 patients applied

Trial Officials

Kirsi M Joronen, PhD

Principal Investigator

Turku University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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