A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Condition: Leiomyoma; Uterine Fibroids; Uterine Neoplasms; Menorrhagia; Leiomyomatosis
MeSH terms: Leiomyoma; Myofibroma; Uterine Neoplasms; Leiomyomatosis; Menorrhagia
Intervention: Uterine Fibroid Embolization (UFE); Contour SE™ Microspheres; Embosphere® Microspheres
Intervention description: Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.; Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations; Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leiomyoma; Uterine Fibroids; Uterine Fibroid Embolization (UFE); Uterine Artery Embolization (UAE); Uterine Neoplasms; Menorrhagia

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 uterine fibroids.
    

Eligibility 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