Status:
COMPLETED
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent
Lead Sponsor:
Worthington-Kirsch, Robert L., M.D.
Collaborating Sponsors:
Terumo Medical Corporation
Biocompatibles UK Ltd
Conditions:
Leiomyoma
Leiomyomatosis
Eligibility:
FEMALE
30-50 years
Phase:
PHASE1
Brief Summary
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison...
Detailed 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 fi...
Eligibility Criteria
Inclusion
- Patient chooses to participate and has signed informed consent
- Age between 30 and 50 years old
- Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
- Patient has fibroids confirmed by MRI
- Patient has normal kidney function.
- Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.
Exclusion
- Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
- Patients with a history of gynecologic malignancy
- Patients with known endometrial hyperplasia
- Patients with adenomyosis
- Patients with pelvic inflammatory disease
- Patients with Uteri \< 250 ml (cm) calculated volume or \> 24 weeks
- Patients with pedunculated subserosal fibroids with a narrow attachment (\<50% diameter of the fibroid) to the uterus.
- Patients with pelvic pain as dominant syndrome
- Known allergy to contrast media that cannot be adequately pre-medicated.
- Patients not suitable for arterial access.
- Previous uterine artery embolization attempts.
- History of pelvic irradiation.
- Patients on GnRH Therapy within 3-6 months prior to the study enrollment.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00361036
Start Date
August 1 2006
End Date
March 1 2010
Last Update
April 18 2011
Active Locations (2)
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1
Albany Medical Center
Albany, New York, United States, 12208
2
Image Guided Surgery Associates
Pottstown, Pennsylvania, United States, 19464