Uterine Fibroids Clinical Trial
Official title:
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
The purpose of this prospective non-randomised study is to examine whether two different
microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the
uterine fibroid controlled with contrast-enhanced MR examination.
Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement
characteristics before intervention and 3 months after interventions will be analysed as a
potential predictor of volumetric response after embolization.
Another purpose is to determine long-term follow-up in all patient treated in a period from
2001-2011 in OUH analysed retrospectively.
Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres
or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm
microspheres until blood flow stop ( " cut the tree" appearance).
Group 2: 26 patient will be treated with Embosphere; 500-900 µm until "near-stasis" flow
stop in the uterine artery.
Clinical and Technical success will be examined, and radiological follow-up 3 and 12 months
after embolization using MR contrast-enhanced examination in a Bead Block group and only 3
months control in Embosphere group to assess total fibroid burden infraction degree and
eventually residual contracts fibroid enhancement.
Quantitative MRI dominant fibroid characteristic for and 3 months after an intervention to
examine eventually potential of as a possible predictor of the volumetric response of the
uterine fibroid.
Retrospective study compromised all patient treated between January 2001 until January 2011
with follow up to January 2014, and re-intervention as well as complications rate analysis.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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