An interventional study of embolizations ,uterine fibroid and embolizations in Uterine Fibroids and Arterial Embolization, sponsored by Odense University Hospital. Completed at 2 sites in Denmark. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 52 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
don,t want to be included into the study
embolization interventions with microspheres
Procedure: embolizations ,uterine fibroid · Procedure: embolizations
26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop ( " cut the tree" appearance) 26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until "near stasis " flow stop
comparison between the two microspheres
Also known as: microsphere, uterine fibroid
clinical effect
Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
Time frame: one year
reinterventions rate
Time frame: one year
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Odense University Hospital