A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE) - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00628901

Purpose

The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.

Condition	Intervention	Phase
Leiomyoma Uterine Fibroids Uterine Neoplasms Menorrhagia Leiomyomatosis	Procedure: Uterine Fibroid Embolization (UFE) Device: Contour SE™ Microspheres Device: Embosphere® Microspheres	Phase IV

MedlinePlus related topics: Cancer Uterine Cancer

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Fibroid devascularization measured by contrast enhanced MRI [ Time Frame: 24-hours post UFE ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum level of nausea and pain [ Time Frame: During the hospitalization stay post UFE ] [ Designated as safety issue: No ]
Fluoroscopy time [ Time Frame: During the hospitalization stay post UFE ] [ Designated as safety issue: No ]
Procedure time [ Time Frame: During the hospitalization stay post UFE ] [ Designated as safety issue: No ]
Any adverse events that the subject experienced [ Time Frame: During the hospitalization stay post UFE, 24 hours, 3 months, and 12 months post procedure ] [ Designated as safety issue: Yes ]
Quality of life questionaire [ Time Frame: Baseline, 3 and 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Procedure: Uterine Fibroid Embolization (UFE) Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure. Device: Contour SE™ Microspheres Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
Arm 2: Active Comparator	Procedure: Uterine Fibroid Embolization (UFE) Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure. Device: Embosphere® Microspheres Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Arms

Assigned Interventions

Arm 1: Experimental

Procedure: Uterine Fibroid Embolization (UFE)

Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.

Device: Contour SE™ Microspheres

Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations

Arm 2: Active Comparator

Procedure: Uterine Fibroid Embolization (UFE)

Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.

Device: Embosphere® Microspheres

Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Detailed Description:

The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced MRI at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MR imaging will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity( QoL Questionnaire) will be assessed at 3 months and 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

One or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure.
Severity of the symptom(s) warrants invasive treatment
Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
Willing to sign a consent form

Exclusion Criteria:

Active pelvic inflammatory disease or infection
Any malignancy of the pelvic region
Endometrial neoplasia or hyperplasia
Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity
Presence of pedunculated serosal fibroid as the dominant fibroid(s)
Fibroids with significant collateral feeding by vessels other than the uterine arteries
Presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres
Coagulopathy
Atypical anatomy that will not allow for bilateral UFE
Subject with known severe contrast allergy
Subjects with known moderate to severe renal disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628901

Contacts

Contact: Tina Drager

651-581-4621

Tina.Drager@bsci.com

Locations

United States, Pennsylvania
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104-3246
Contact: Alexis Hayes, ASRT 215-615-4142 alexis.hayes@uphs.upenn.edu
Principal Investigator: Richard Shlansky-Goldberg, MD

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Richard Shalansky-Goldberg, MD	University of Pennsylvania
Study Director:	Pamela Grady, Ph.D	Boston Scientific Corporation

More Information

Responsible Party:	Boston Scientific ( Tina Drager, Clinical Project Manager )
Study ID Numbers:	M9011, ONC-PM-022005
Study First Received:	February 25, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00628901
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

Leiomyoma
Uterine Fibroids
Uterine Fibroid Embolization
Uterine Artery Embolization

UFE
UAE
Uterine Neoplasms
Menorrhagia

Study placed in the following topic categories:

Myofibroma
Leiomyomatosis
Uterine Hemorrhage
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Hemorrhage
Leiomyoma

Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Menstruation Disturbances
Connective Tissue Diseases
Uterine Neoplasms
Menorrhagia
Ethanol

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Site

Pathologic Processes
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 16, 2009