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A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
This study is ongoing, but not recruiting participants.
First Received: February 25, 2008   Last Updated: January 28, 2010   History of Changes
Sponsor: 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

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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Uterine Cancer
U.S. FDA Resources

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 ]

Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: January 2011
Primary Completion Date: December 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.

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

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3246
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

No publications provided

Responsible Party: Boston Scientific ( Anastasia Becker, Clinical Program Manager )
Study ID Numbers: M9011, ONC-PM-022005
Study First Received: February 25, 2008
Last Updated: January 28, 2010
ClinicalTrials.gov Identifier: NCT00628901     History of Changes
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

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

ClinicalTrials.gov processed this record on February 08, 2010



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