Status:
COMPLETED
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Leiomyoma
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uteri...
Detailed Description
The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Micr...
Eligibility Criteria
Inclusion
- One or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure.
- Severity of the symptom(s) warrants invasive treatment
- Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
- Willing to sign a consent form
Exclusion
- Active pelvic inflammatory disease or infection
- Any malignancy of the pelvic region
- Endometrial neoplasia or hyperplasia
- Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity
- Presence of pedunculated serosal fibroid as the dominant fibroid(s)
- Fibroids with significant collateral feeding by vessels other than the uterine arteries
- Presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres
- Coagulopathy
- Atypical anatomy that will not allow for bilateral UFE
- Subject with known severe contrast allergy
- Subjects with known moderate to severe renal disease
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00628901
Start Date
January 1 2006
End Date
January 1 2011
Last Update
July 11 2012
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3246