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

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ClinicalTrials.gov Identifier: NCT02914704
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

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 and with no wish for further pregnancies will be selected for this study and treated using MRI-HIFU. 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Adenomyosis Device: MRI-HIFU Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Diseases

Arm Intervention/treatment
Experimental: Patients treated with MRI-HIFU Device: MRI-HIFU
Treatment of uterine fibroids with MRI-HIFU




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 35
  • Premenopausal
  • Menstrual cycle 24-35 days
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914704


Contacts
Contact: Kirsi M Joronen, PhD kirsi.joronen@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Kirsi M Joronen, MD PhD    +35823130561    kirsi.joronen@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Kirsi M Joronen, PhD Turku University Hospital

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02914704     History of Changes
Other Study ID Numbers: GYN-HIFU
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Adenomyosis
Uterine Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Diseases, Female