Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

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

Embosphere®

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.

Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids

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.

Boston Scientific Corporation

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

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.

Embosphere®

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The trial was terminated early due to insufficient enrollment, therefore formal statistical analyses were not possible.

Anastasia Becker - Director of Clinical Trials

The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Embozene Microspheres for Uterine Fibroid Embolization (UFE)	NCT01675011	Uterine Fibroid...	Embozene® Micro... Embosphere®	30 Years - 50 Years	Boston Scientific Corporation
Embozene Microspheres for Uterine Fibroid Embolization (UFE)	NCT01675011	Uterine Fibroid...	Embozene® Micro... Embosphere®	30 Years - 50 Years	Boston Scientific Corporation

Spots Global Cancer Trial Database for embozene® microspheres