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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

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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 Center Albany, New York  12208
North Shore LIJ Medical Center New Hyde Park, New York