Leiomyoma, Leiomyomatosis, Uterine Neoplasms
Conditions
Keywords
Leiomyoma, Leiomyomatosis, Uterine Neoplasms, BeadBlock, Embsophere, Embolization, Uterine fibroid embolization
Brief 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.
Detailed description
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.
Interventions
DEVICEUterine fibroid embolization BeadBlock™
Intervention with BeadBlock Microspehere
DEVICEUterine fibroid embolization Embosphere®
Embosphere - control arm
Sponsors
Terumo Medical Corporation
Biocompatibles UK Ltd
Worthington-Kirsch, Robert L., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed