Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01675011
• Other study ID #: 2010-001
• Status: Terminated
• Phase: N/A
• First received: August 25, 2012
• Last updated: February 10, 2016
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Device:
• Embozene® Microspheres

• Embosphere®

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	North Shore LIJ Medical Center	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	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.	12 Months post study procedure	Yes