Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852734
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Stevo Duvnjak,MD, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Uterine Fibroids Arterial Embolization Procedure: embolizations ,uterine fibroid Procedure: embolizations Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Study Start Date : November 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
embolizations, uterine fibroid
embolization interventions with microspheres
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


Procedure: embolizations
comparison between the two microspheres
Other Name: microsphere, uterine fibroid




Primary Outcome Measures :
  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 Outcome Measures :
  1. reinterventions rate [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852734


Locations
Layout table for location information
Denmark
Odense University Hospital
Odense, Fyn, Denmark, 5000
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Stevo Duvnjak, MD Odense University Hospital
Layout table for additonal information
Responsible Party: Stevo Duvnjak,MD, Medical Doctor, Radiologist, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01852734    
Other Study ID Numbers: OUH-2013
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases