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Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

NCT01852734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-11-28

No results posted yet for this study

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.

Conditions

  • Uterine Fibroids
  • Arterial Embolization

Interventions

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

PROCEDURE

embolizations

comparison between the two microspheres

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Stevo Duvnjak, MD · Odense University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852734 on ClinicalTrials.gov