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Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01852734
Enrollment
52
Registered
2013-05-14
Start date
2013-11-30
Completion date
2016-04-30
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Embolization, Uterine Fibroids

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.

Detailed description

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.

Interventions

PROCEDUREembolizations ,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

PROCEDUREembolizations

comparison between the two microspheres

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No

Inclusion criteria

* symptomatic uterus fibroma

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
clinical effectone yearPrimary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques

Secondary

MeasureTime frame
reinterventions rateone year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026