Know Cancer

or
forgot password

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


N/A
30 Years
50 Years
Open (Enrolling)
Female
Uterine Fibroids

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Primary Endpoint

Outcome 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.

Outcome Time Frame:

12 Months post study procedure

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2010-001

NCT ID:

NCT01675011

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Albany Medical CenterAlbany, New York  12208
North Shore LIJ Medical CenterNew Hyde Park, New York