Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Primary Purpose
Uterine Fibroids, Arterial Embolization
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
embolizations ,uterine fibroid
embolizations
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
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
Sites / Locations
- Odense University Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
embolizations, uterine fibroid
Arm Description
embolization interventions with microspheres
Outcomes
Primary Outcome Measures
clinical effect
Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
Secondary Outcome Measures
reinterventions rate
Full Information
NCT ID
NCT01852734
First Posted
May 6, 2013
Last Updated
November 23, 2016
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01852734
Brief Title
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Official Title
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Arterial Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
embolizations, uterine fibroid
Arm Type
Other
Arm Description
embolization interventions with microspheres
Intervention Type
Procedure
Intervention Name(s)
embolizations ,uterine fibroid
Intervention Description
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
Intervention Name(s)
embolizations
Other Intervention Name(s)
microsphere, uterine fibroid
Intervention Description
comparison between the two microspheres
Primary Outcome Measure Information:
Title
clinical effect
Description
Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
Time Frame
one year
Secondary Outcome Measure Information:
Title
reinterventions rate
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stevo Duvnjak, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
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Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
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