Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Uterine Fibroids Clinical Trial

Official title:

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852734
• Other study ID #: OUH-2013
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: November 23, 2016
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arterial Embolization
• Leiomyoma
• Uterine Fibroids

Intervention

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
• embolizations
comparison between the two microspheres

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical effect	Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques	one year	Yes
Secondary	reinterventions rate		one year	Yes