Trials / Unknown
UnknownNCT02914704
Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Turku University Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MRI-HIFU | Treatment of uterine fibroids with MRI-HIFU |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2016-09-26
- Last updated
- 2019-04-29
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT02914704. Inclusion in this directory is not an endorsement.