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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Leiomyoma, Leiomyomatosis, Uterine Neoplasms

Intervention / Treatment
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* Device: Uterine fibroid embolization BeadBlock™
* Device: Uterine fibroid embolization Embosphere®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BeadBlock treatment arm | Device: Uterine fibroid embolization BeadBlock™<br>* Intervention with BeadBlock Microspehere<br>|
| Active Comparator: 2<br>Embospheres control arm | Device: Uterine fibroid embolization Embosphere®<br>* Embosphere - control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference of change in fibroid devascularization CEMRI performed several days after UAE and 6 months following the UAE between BeadBlock™ and Embosphere. |  | 12 months | 
| assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, Leiomyomatosis, Uterine Neoplasms, BeadBlock, Embsophere, Embolization, Uterine fibroid embolization