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A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE) - NCT00628901-19104(Clinical Trial 206866)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Leiomyoma - Uterine Fibroids - Uterine Neoplasms - Menorrhagia - Leiomyomatosis
Purpose: 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 uterine fibroids.
Study summary: 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® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced MRI at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MR imaging will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity( QoL Questionnaire) will be assessed at 3 months and 12 months.
Criteria: Inclusion Criteria: - 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 Criteria: - 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
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Data Source: ClinicalTrials.gov
Date Processed: January 19, 2010
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