Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlockâ„¢ Embolic Agent
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.
The purpose of the study is to conduct a comparison between BeadBlockâ„˘ 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 Blockâ„˘ and EmbosphereÂ®.
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.
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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Uterine fibroid embolization BeadBlockâ„˘, Uterine fibroid embolization EmbosphereÂ®
Albany Medical Center
Active, not recruiting
Worthington-Kirsch, Robert L., M.D.
Results (where available)
- 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.
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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