Phase 4
N=60
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
Leiomyoma · Uterine Fibroids · Uterine Neoplasms · Menorrhagia · Leiomyomatosis
Bottom Line
View on ClinicalTrials.gov: NCT00628901 ↗Enrolled (actual)
60
Serious AEs
6.7%
Results posted
Aug 2011
Primary outcome: Primary: Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) — 29; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Uterine Fibroid Embolization (UFE) (Procedure); Contour SE™ Microspheres (Device); Embosphere® Microspheres (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI) |
29; 29 | — |
| SECONDARY Visual Analog Scale (VAS) Maximum Level of Nausea |
5.5; 4.8 | — |
| SECONDARY Visual Analog Scale (VAS) Maximum Level of Pain |
6.0; 5.6 | — |
| SECONDARY Fluoroscopy Time |
31.1; 24.9 | — |
| SECONDARY Procedure Time |
102; 95.6 | — |
| SECONDARY Any Adverse Events That the Participant Experienced |
68; 58 | — |
| SECONDARY Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score |
18.0; 22.9 | — |
| SECONDARY Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score |
18.0; 22.9 | — |
| SECONDARY Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score |
18.0; 22.9 | — |
| SECONDARY Health Related Quality of Life (HRQL)Subscores |
42.1; 42.0 | — |
| SECONDARY Health Related Quality of Life Subscores |
89.8; 89.9 | — |
| SECONDARY Health Related Quality of Life Subscores |
89.8; 89.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00628901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.