Back to resultsEmbozene Microspheres for Uterine Fibroid Embolization (UFE)
Primary Purpose
Uterine Fibroids
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embozene® Microspheres
Embosphere®
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
Eligibility 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.
Sites / Locations
- Albany Medical Center
- North Shore LIJ Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Embozene® Microspheres
Embosphere®
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Primary Endpoint
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01675011
First Posted
August 25, 2012
Last Updated
February 10, 2016
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01675011
Brief Title
Embozene Microspheres for Uterine Fibroid Embolization (UFE)
Official Title
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Embozene® Microspheres
Arm Type
Experimental
Arm Description
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.
Arm Title
Embosphere®
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Embozene® Microspheres
Intervention Type
Device
Intervention Name(s)
Embosphere®
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
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.
Time Frame
12 Months post study procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
Country
United States
Facility Name
North Shore LIJ Medical Center
City
New Hyde Park
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Embozene Microspheres for Uterine Fibroid Embolization (UFE)
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