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

Worthington-Kirsch, Robert L., M.D.44 enrolled

Overview

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 1. 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. 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Leiomyoma Leiomyomatosis Uterine Neoplasms

Interventions

Uterine fibroid embolization BeadBlock™DEVICE

Intervention with BeadBlock Microspehere

Uterine fibroid embolization Embosphere®DEVICE

Embosphere - control arm

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (2)

Albany Medical Center

Albany, New York, United States

Image Guided Surgery Associates

Pottstown, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

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

Time frame: 12 months

Data from ClinicalTrials.gov

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