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Occlusin 500 microspheres will be administered using a catheter directed to the uterine vasculature using fluoroscopy. The microsphere suspension will be administered to a near-stasis endpoint.

Occlusin 500 Microspheres

Richard Owen, MD

This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.

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.

OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

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

Qualitative assessment of uterus comparing baseline to post-embolization time points

Magnetic Resonance Imaging-determined fibroid volume

Magnetic Resonance Imaging-determined uterine volume

Uterine Fibroid Symptom Assessment by Questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids	NCT03427671	Uterine Fibroid Myoma Leiomyoma	Occlusin 500 Mi...	-	IMBiotechnologies Ltd.
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids	NCT03427671	Uterine Fibroid Myoma Leiomyoma	Occlusin 500 Mi...	-	IMBiotechnologies Ltd.

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