Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent - Full Text View

Sponsor:	Worthington-Kirsch, Robert L., M.D.
Collaborators:	Terumo Medical Corporation Biocompatibles UK Ltd
Information provided by:	Worthington-Kirsch, Robert L., M.D.
ClinicalTrials.gov Identifier:	NCT00361036

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 I

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:

MedlinePlus related topics: Cancer Uterine Cancer

U.S. FDA Resources

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

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.
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:

Patient chooses to participate and has signed informed consent
Age between 30 and 50 years old
Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
Patient has fibroids confirmed by MRI
Patient has normal kidney function.
Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.

Exclusion Criteria:

Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
Patients with a history of gynecologic malignancy
Patients with known endometrial hyperplasia
Patients with adenomyosis
Patients with pelvic inflammatory disease
Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks
Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus.
Patients with pelvic pain as dominant syndrome
Known allergy to contrast media that cannot be adequately pre-medicated.
Patients not suitable for arterial access.
Previous uterine artery embolization attempts.
History of pelvic irradiation.
Patients on GnRH Therapy within 3-6 months prior to the study enrollment.

Contacts and Locations

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:

Management of Uterine fibroids Summary report This link exits the ClinicalTrials.gov site

Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids This link exits the ClinicalTrials.gov site

Management of Uterine Fibroids Volume 1. Evidence Report This link exits the ClinicalTrials.gov site

Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial This link exits the ClinicalTrials.gov site

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Worthington-Kirsch RL, Siskin GP, Hegener P, Chesnick R. Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial. Cardiovasc Intervent Radiol. 2011 Jun;34(3):493-501. Epub 2010 Dec 3.

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:

Neoplasms
Leiomyoma
Myofibroma
Uterine Neoplasms
Leiomyomatosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012