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

April 14, 2011 updated by: Worthington-Kirsch, Robert L., M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Image Guided Surgery Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome 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.
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Terumo Medical Corporation
Biocompatibles UK Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (ESTIMATE)

August 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 14, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G060030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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