Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Not Applicable

Terminated

• Conditions: Uterine Fibroids
• Interventions: Device: Embosphere®; Device: Embozene® Microspheres

• Registration Number: NCT01675011
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-25
• Study First Submitted QC: 2012-08-25
• Study First Posted: 2012-08-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-01-28
• Results First Submitted QC: 2015-01-28
• Results First Posted: 2015-02-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embosphere®	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.
Embozene® Microspheres	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.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	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.

Trial Locations

Locations (2)

Albany Medical Center; 🇺🇸 Albany, New York, United States

North Shore LIJ Medical Center; 🇺🇸 New Hyde Park, New York, United States