Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlockâ„¢ Embolic Agent
Summary
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlockâ„¢ in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome with comparison of primary safety endpoints to Embosphere.
Description
The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a 12 months study (12 month follow up for all enrollees). The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/- 15 days) after UAE procedure. In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.
Primary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the UAE, and compare the changes between BeadBlockâ„¢ and Embosphere.
Secondary Objective
1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlockâ„¢ and Embosphere.
Tertiary Objective
1. To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlockâ„¢ and Embosphere.
2. To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and compare the changes between BeadBlockâ„¢ and Embosphere.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Leiomyoma
Intervention
Uterine fibroid embolization BeadBlock™, Uterine fibroid embolization Embosphere®
Location
Albany Medical Center
Albany
New York
United States
12208
Status
Active, not recruiting
Source
Worthington-Kirsch, Robert L., M.D.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00361036
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Uterine Artery Embolization
The use of embolizing agents to block the arterial blood supply to parts or all of the UTERUS. The procedures are done to control bleeding or to cause destruction of uterine tissues.
Uterine Balloon Tamponade
Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.
Uterine Monitoring
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Uterine Cervical Neoplasms
Tumors or cancer of the UTERINE CERVIX.
Uterine Cervical Diseases
Pathological processes of the UTERINE CERVIX.
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PubMed Articles
PURPOSE: To compare the status of uterine and ovarian arteries after uterine artery embolization (UAE) in patients with incomplete and complete fibroid infarction via unenhanced 3D time-of-flight magn...
PURPOSE: We have observed significant rates of uterine artery patency after uterine artery embolization (UAE) with nonspherical polyvinyl alcohol (nsPVA) on 6Â month follow-up MR scanning. The study a...
Utility of MRI Before and After Uterine Fibroid Embolization: Why to Do It and What to Look For.
The utility of magnetic resonance imaging (MRI) in the selection, procedure planning, and follow-up of patients undergoing arterial embolization for uterine fibroids is reviewed. Advantages of MRI ove...
A Neurological Complication of a Uterine Fibroid.
BACKGROUND: Uterine leiomyoma (or fibroid) can be associated with secondary polycythemia and venous thrombosis, but there has been no report of intracranial venous thrombosis ass...
Assessing the Reliability and Quality of Online Uterine Fibroid Embolization Resources.
PURPOSE: This study was designed to examine the best internet resources about uterine fibroid embolization (UFE) pertinent to medical trainees, radiologists, gynecologists, family physicians, and pati...
