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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
University of Alberta Hospital
Edmonton, Alberta, Canada
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Time frame: 6 months post-embolization
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Time frame: 1 month post-embolization
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Time frame: 6 months post-embolization
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Time frame: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Time frame: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Time frame: 6 month post-embolization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.