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Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

18 Years
50 Years
Not Enrolling
Uterine Fibroids, Arterial Embolization

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Trial Information

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

60 patients randomise in the two groups each group consist of the 30 patients. Group 1: 30
patients treat with Bead-block microparticles, 700-900µm until flowstop.

Group 2: 30 patient treat with Bead-block microparticles, combinations of the 1ml -500-700
µm particle, if a.uterine is < 3 mm, follow by 700-900 µm particle until blood flowstop
or with 2 ml -500-700 µm particle if arteria uterine has diameter of > 3 mm follow by
embolisation with 700-900 µm particle until blood flowstop.

Clinical and technical success as well as clinic and radiological follow up after 3 and 12
months. MR of the pelvis examination with contrast, 3 and 12 month after intervention will
control infraction degree.

Retrospective study compromised all patient treated between 2001 until 2011 with follow up
and re-intervention as well as complications rate analysis.

Inclusion Criteria:

- symptomatic uterus fibroma

Exclusion Criteria:

- pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis)

- gravidity

- uterus malignancy

- big submucosal fibroma > 50 % af uterus

- >50 age

- don,t want to be included into the study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical effect

Outcome Description:

Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Stevo Duvnjak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital


Denmark: Ethics Committee

Study ID:




Start Date:

July 2013

Completion Date:

April 2015

Related Keywords:

  • Uterine Fibroids
  • Arterial Embolization
  • Leiomyoma
  • Myofibroma