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

Phase 4
18 Years
Not Enrolling
Leiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia, Leiomyomatosis

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)

Outcome Description:

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).

Outcome Time Frame:

24-hours post study procedure

Safety Issue:


Principal Investigator

Richard Shalansky-Goldberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

January 2011

Related Keywords:

  • Leiomyoma
  • Uterine Fibroids
  • Uterine Neoplasms
  • Menorrhagia
  • Leiomyomatosis
  • Leiomyoma
  • Uterine Fibroids
  • Uterine Fibroid Embolization (UFE)
  • Uterine Artery Embolization (UAE)
  • Uterine Neoplasms
  • Menorrhagia
  • Neoplasms
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Uterine Neoplasms
  • Leiomyomatosis



Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104