Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®

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.

The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a 12 months study (12 month follow up for all enrollees). The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/- 15 days) after UAE procedure. In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block™ and Embosphere®. Primary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere. Secondary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere. Tertiary Objective To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere. To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and compare the changes between BeadBlock™ and Embosphere.

Leiomyoma, Leiomyomatosis, Uterine Neoplasms, BeadBlock, Embsophere, Embolization, Uterine fibroid embolization

Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere

Mean difference of change in fibroid devascularization CEMRI performed several days after UAE and 6 months following the UAE between BeadBlock™ and Embosphere.

assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up

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

Worthington-Kirsch RL, Siskin GP, Hegener P, Chesnick R. Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial. Cardiovasc Intervent Radiol. 2011 Jun;34(3):493-501. doi: 10.1007/s00270-010-0049-y. Epub 2010 Dec 3.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=16260201

Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial