Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Boston Scientific

Status: Terminated

Conditions: Uterine Fibroids

Treatments: Device: Embosphere®; Device: Embozene® Microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT01675011

2010-001

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Embozene® Microspheres

Experimental group

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.

Treatment:

Device: Embozene® Microspheres

Embosphere®

Active Comparator group

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.

Treatment:

Device: Embosphere®