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

NCT ID: NCT00628901

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-01-31

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.

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 Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI 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 (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.

Conditions

Leiomyoma; Uterine Fibroids; Uterine Neoplasms; Menorrhagia; Leiomyomatosis

Keywords

Leiomyoma; Uterine Fibroids; Uterine Fibroid Embolization (UFE); Uterine Artery Embolization (UAE); Uterine Neoplasms; Menorrhagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Uterine Fibroid Embolization (UFE)

Intervention Type: PROCEDURE

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.

Contour SE™ Microspheres

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Uterine Fibroid Embolization (UFE)

Intervention Type: PROCEDURE

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.

Embosphere® Microspheres

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

Embosphere® Microspheres

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Shalansky-Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Pamela Grady, Ph.D

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24788209 (View on PubMed)

Other Identifiers

ONC-PM-022005

Identifier Type: -

Identifier Source: secondary_id

M9011

Identifier Type: -

Identifier Source: org_study_id