Skip to main content
OpenTrials
Completed

NCT Number: NCT01852734

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

embolizations ,uterine fibroid

Procedure

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

embolizations

Procedure

comparison between the two microspheres

Other names: microsphere, uterine fibroid

Primary outcomes

  1. clinical effect

    Time frame: one year

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

Secondary outcomes

  1. reinterventions rate

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 14, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.