Clinical trial · Interventional
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)
NCT00628901CI-TRIAL-00007373completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Leiomyomatosis | Leiomyomatosis | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contour SE™ Microspheres | Device | — | UNRESOLVED |
| Embosphere® Microspheres | Device | — | UNRESOLVED |
| Uterine Fibroid Embolization (UFE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Procedure: Uterine Fibroid Embolization (UFE)
- Device: Contour SE™ Microspheres
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- interventionNames
- Procedure: Uterine Fibroid Embolization (UFE)
- Device: Embosphere® Microspheres
Primary outcomes (1)
- measure
- Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
- timeFrame
- 24-hours post study procedure
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShlansky-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 24788209