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Embozene Microspheres for Uterine Fibroid Embolization (UFE)

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: NCT01675011
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : August 29, 2012
Results First Posted : February 12, 2015
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Device: Embozene® Microspheres Device: Embosphere® Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
Study Start Date : August 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Embozene® Microspheres
Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
 Device: Embozene® Microspheres
Active Comparator: Embosphere®
Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
 Device: Embosphere®


Outcome Measures
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Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: 12 Months post study procedure ]
    The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
  • Pre-menopausal women age 30-50 years at time of enrollment
  • Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.

Exclusion Criteria:

  • Patient has a history of pelvic malignancy
  • Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
  • Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
  • Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
  • Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
  • Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
  • Patients unable to comply with the follow-up requirements of the study.
Contacts and Locations
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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): NCT01675011


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States
North Shore LIJ Medical Center
New Hyde Park, New York, United States
Sponsors and Collaborators
Boston Scientific Corporation
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01675011    
Other Study ID Numbers: 2010-001
First Posted: August 29, 2012    Key Record Dates
Results First Posted: February 12, 2015
Last Update Posted: March 11, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases