Embozene Microspheres for Uterine Fibroid Embolization (UFE)

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier:
NCT01675011
First received: August 25, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Uterine Fibroids
Device: Embozene® Microspheres
Device: Embosphere®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids

Further study details as provided by CeloNova BioSciences, Inc.:

Primary Outcome Measures:
  • Primary Endpoint [ Time Frame: 12 Months post study procedure ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 4
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Embozene® Microspheres
Active Comparator: Embosphere®
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.
Device: Embosphere®

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675011

Locations
United States, New York
Albany Medical Center
Albany, New York, United States
North Shore LIJ Medical Center
New Hyde Park, New York, United States
Sponsors and Collaborators
CeloNova BioSciences, Inc.
  More Information

No publications provided

Responsible Party: CeloNova BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01675011     History of Changes
Other Study ID Numbers: 2010-001
Study First Received: August 25, 2012
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 11, 2014