Clinical trial NCT00628901: A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leiomyoma
Uterine Fibroids
Uterine Neoplasms
Menorrhagia
Leiomyomatosis
Keywords: Leiomyoma
Uterine Fibroids
Uterine Fibroid Embolization (UFE)
Uterine Artery Embolization (UAE)
Uterine Neoplasms
Menorrhagia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
timeFrame: 24-hours post study procedure
Secondary outcomes:
measure: Visual Analog Scale (VAS) Maximum Level of Nausea
timeFrame: 24 hours after study procedure
measure: Visual Analog Scale (VAS) Maximum Level of Pain
timeFrame: 24 hours after study procedure
measure: Fluoroscopy Time
timeFrame: During the study procedure (measured in minutes)
measure: Procedure Time
timeFrame: During the study procedure (measured in minutes)
measure: Any Adverse Events That the Participant Experienced
timeFrame: During the hospitalization stay post UFE
measure: Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
timeFrame: Baseline
measure: Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
timeFrame: 3-months
measure: Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score
timeFrame: 12 months
measure: Health Related Quality of Life (HRQL)Subscores
timeFrame: Baseline
measure: Health Related Quality of Life Subscores
timeFrame: 3 months
measure: Health Related Quality of Life Subscores
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Richard Shalansky-Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Pamela Grady, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.