Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
|ClinicalTrials.gov Identifier: NCT01852734|
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids Arterial Embolization||Procedure: embolizations ,uterine fibroid Procedure: embolizations||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
embolizations, uterine fibroid
embolization interventions with microspheres
Procedure: embolizations ,uterine fibroid
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
Other Name: microsphere, uterine fibroid
- clinical effect [ Time Frame: one year ]Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
- reinterventions rate [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852734
|Odense University Hospital|
|Odense, Fyn, Denmark, 5000|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Stevo Duvnjak, MD||Odense University Hospital|