A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

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.

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 Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI 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 (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.

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