Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
18 Years
50 Years
Female
Uterine Fibroids, Arterial Embolization
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:
Interventional
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:
Yes
Principal Investigator
Stevo Duvnjak, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Odense University Hospital
Authority:
Denmark: Ethics Committee
Study ID:
OUH-2013
NCT ID:
NCT01852734
Start Date:
July 2013
Completion Date:
April 2015
Related Keywords:
- Uterine Fibroids
- Arterial Embolization
- Leiomyoma
- Myofibroma
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