A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
August 22, 2011
CompletedJuly 11, 2012
July 1, 2012
3.9 years
February 25, 2008
June 13, 2011
July 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).
24-hours post study procedure
Secondary Outcomes (11)
Visual Analog Scale (VAS) Maximum Level of Nausea
24 hours after study procedure
Visual Analog Scale (VAS) Maximum Level of Pain
24 hours after study procedure
Fluoroscopy Time
During the study procedure (measured in minutes)
Procedure Time
During the study procedure (measured in minutes)
Any Adverse Events That the Participant Experienced
During the hospitalization stay post UFE
- +6 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
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.
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
Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3246, United States
Related Publications (1)
Shlansky-Goldberg RD, Rosen MA, Mondschein JI, Stavropoulos SW, Trerotola SO, Diaz-Cartelle J. Comparison of polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine fibroid embolization: results of a single-center randomized study. J Vasc Interv Radiol. 2014 Jun;25(6):823-32. doi: 10.1016/j.jvir.2014.03.009. Epub 2014 Apr 29.
PMID: 24788209DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ana Becker / Sr. Clinical Program Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Shalansky-Goldberg, MD
University of Pennsylvania
- STUDY DIRECTOR
Pamela Grady, Ph.D
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 5, 2008
Study Start
January 1, 2006
Primary Completion
December 1, 2009
Study Completion
January 1, 2011
Last Updated
July 11, 2012
Results First Posted
August 22, 2011
Record last verified: 2012-07