Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

NCT ID: NCT01852734

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Uterine Fibroids; Arterial Embolization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

embolizations, uterine fibroid

embolization interventions with microspheres

Group Type: OTHER

embolizations ,uterine fibroid

Intervention Type: 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

Intervention Type: PROCEDURE

comparison between the two microspheres

Interventions

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

Intervention Type: PROCEDURE

embolizations

comparison between the two microspheres

Intervention Type: PROCEDURE

Other Intervention Names

microsphere, uterine fibroid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stevo Duvnjak,MD

Medical Doctor, Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stevo Duvnjak, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Odense University Hospital

Odense, Denmark, Denmark

Odense University Hospital

Odense, Fyn, Denmark

Countries

Denmark

Other Identifiers

OUH-2013

Identifier Type: -

Identifier Source: org_study_id