Embozene Microspheres for Uterine Fibroid Embolization (UFE)
| Status: | Terminated |
|---|---|
| Conditions: | Cervical Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | December 2013 |
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
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.
with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six
(36) months following uterine fibroid embolization.
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.
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