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 of primary safety endpoints to Embosphere.
Key Facts
Lead Sponsor
Enrollment
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Completion Date
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Eligibility
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Inclusion Criteria: 1. Patient chooses to participate and has signed informed consent 2. Age between 30 and 50 years old 3. Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain. 4. Patient has fibroids confirmed by MRI 5. Patient has normal kidney function. 6. Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE. Exclusion Criteria: 1. Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility. 2. Patients with a history of gynecologic malignancy 3. Patients with known endometrial hyperplasia 4. Patients with adenomyosis 5. Patients with pelvic inflammatory disease 6. Patients with Uteri \< 250 ml (cm) calculated volume or \> 24 weeks 7. Patients with pedunculated subserosal fibroids with a narrow attachment (\<50% diameter of the fibroid) to the uterus. 8. Patients with pelvic pain as dominant syndrome 9. Known allergy to contrast media that cannot be adequately pre-medicated. 10. Patients not suitable for arterial access. 11. Previous uterine artery embolization attempts. 12. History of pelvic irradiation. 13. Patients on GnRH Therapy within 3-6 months prior to the study enrollment.