Clinical trial · Interventional
Embozene Microspheres for Uterine Fibroid Embolization (UFE)
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
NCT01675011CI-TRIAL-00021329terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate enrollment
Summary
Brief summary (as posted)
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embosphere® | Device | — | UNRESOLVED |
| Embozene® Microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Embozene® Microspheres
- description
- Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
- interventionNames
- Device: Embozene® Microspheres
- type
- ACTIVE_COMPARATOR
- label
- Embosphere®
- description
- Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
- interventionNames
- Device: Embosphere®
Primary outcomes (1)
- measure
- Primary Endpoint
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form. * Pre-menopausal women age 30-50 years at time of enrollment * Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study. Exclusion Criteria: * Patient has a history of pelvic malignancy * Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure * Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts). * Is at substantial risk for the need of organ transplantation, such as renal insufficiency. * Patient has evidence of current or recent pelvic inflammatory disease or uterine infection. * Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents. * Patients unable to comply with the follow-up requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.