Embozene Microspheres for Uterine Fibroid Embolization (UFE)

NCT ID: NCT01675011

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Embozene® Microspheres

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Embosphere®

Intervention Type: DEVICE

Interventions

Embozene® Microspheres

Intervention Type: DEVICE

Embosphere®

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Albany Medical Center

Albany, New York, United States

North Shore LIJ Medical Center

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

2010-001

Identifier Type: -

Identifier Source: org_study_id