Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®
30 Years
50 Years
Female
Leiomyoma, Leiomyomatosis, Uterine Neoplasms
Trial Information
Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Robert Worthington-Kirsch, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Image Guided Surgery Associates
Authority:
United States: Food and Drug Administration
Study ID:
G060030
NCT ID:
NCT00361036
Start Date:
August 2006
Completion Date:
March 2010
Related Keywords:
- Leiomyoma
- Leiomyomatosis
- Uterine Neoplasms
- Leiomyoma
- Leiomyomatosis
- Uterine Neoplasms
- BeadBlock
- Embsophere
- Embolization
- Uterine fibroid embolization
- Neoplasms
- Leiomyoma
- Myofibroma
- Uterine Neoplasms
- Leiomyomatosis
Name | Location |
|---|---|
| Albany Medical Center | Albany, New York 12208 |
| Image Guided Surgery Associates | Pottstown, Pennsylvania 19464 |
