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

This study has been completed.
Sponsor:
Collaborators:
Terumo Medical Corporation
Biocompatibles UK Ltd
Information provided by:
Worthington-Kirsch, Robert L., M.D.
ClinicalTrials.gov Identifier:
NCT00361036
First received: August 3, 2006
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Leiomyoma
Leiomyomatosis
Uterine Neoplasms
Device: Uterine fibroid embolization BeadBlock™
Device: Uterine fibroid embolization Embosphere®
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Worthington-Kirsch, Robert L., M.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BeadBlock treatment arm
Device: Uterine fibroid embolization BeadBlock™
Intervention with BeadBlock Microspehere
Active Comparator: 2
Embospheres control arm
Device: Uterine fibroid embolization Embosphere®
Embosphere - control arm

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.
  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361036

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United States, Pennsylvania
Image Guided Surgery Associates
Pottstown, Pennsylvania, United States, 19464
Sponsors and Collaborators
Worthington-Kirsch, Robert L., M.D.
Terumo Medical Corporation
Biocompatibles UK Ltd
Investigators
Principal Investigator: Robert Worthington-Kirsch, MD Image Guided Surgery Associates
  More Information

Additional Information:
No publications provided by Worthington-Kirsch, Robert L., M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Worthington-Kirsch MD, Image Guided Surgery associates
ClinicalTrials.gov Identifier: NCT00361036     History of Changes
Other Study ID Numbers: G060030
Study First Received: August 3, 2006
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Worthington-Kirsch, Robert L., M.D.:
Leiomyoma
Leiomyomatosis
Uterine Neoplasms
BeadBlock
Embsophere
Embolization
Uterine fibroid embolization

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Leiomyomatosis
Neoplasms
Uterine Neoplasms
Connective Tissue Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Urogenital Neoplasms
Uterine Diseases

ClinicalTrials.gov processed this record on October 22, 2014