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Brief Title: OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
Official Title: An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Study ID: NCT03427671
Brief Summary: This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
Detailed Description: Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
University of Alberta Hospital, Edmonton, Alberta, Canada
Name: Richard Owen, MD
Affiliation: University of Alberta
Role: PRINCIPAL_INVESTIGATOR