Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
1 other identifier
interventional
52
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedNovember 28, 2016
November 1, 2016
2.4 years
May 6, 2013
November 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
clinical effect
Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
one year
Secondary Outcomes (1)
reinterventions rate
one year
Study Arms (1)
embolizations, uterine fibroid
OTHERembolization interventions with microspheres
Interventions
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
Eligibility Criteria
You may qualify if:
- symptomatic uterus fibroma
You may not qualify if:
- pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis)
- gravidity
- uterus malignancy
- big subserosal fibroma with stalk diameter of \<2 cm
- menopausal women
- don,t want to be included into the study
- concomitant adenomyosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Odense University Hospital
Odense, Denmark, 5000, Denmark
Odense University Hospital
Odense, Fyn, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stevo Duvnjak, MD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Radiologist
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 14, 2013
Study Start
November 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
November 28, 2016
Record last verified: 2016-11