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

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361036
• Other study ID #: G060030
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2006
• Last updated: April 14, 2011
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Worthington-Kirsch, Robert L., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyomatosis
• Uterine Neoplasms

Intervention

Device:
• Uterine fibroid embolization BeadBlock™
Intervention with BeadBlock Microspehere
• Uterine fibroid embolization Embosphere®
Embosphere - control arm

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Image Guided Surgery Associates	Pottstown	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Worthington-Kirsch, Robert L., M.D.	Biocompatibles UK Ltd, Terumo Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up		12 months	No

External Links

•   Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
•   Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial
•   Uterine fibroid embolization