Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Stopped early · Not applicable

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID: NCT01675011
Run by: Boston Scientific Corporation
People needed: 4
Starts: 2012-08-01
Expected to finish: 2013-12-01
Last updated by the study team: 2016-03-11

Who can join

Age: 30 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Albany Medical Center — Albany, New York, United States
North Shore LIJ Medical Center — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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