OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

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

Detailed Description
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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.

Official Title
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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

Conditions
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Uterine Fibroid, Myoma, Leiomyoma

Intervention / Treatment
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* Device: Occlusin 500 Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal women with symptomatic uterine fibroids Willing and able to provide informed consent Fibroids visible by ultrasound or non-contrast magnetic resonance imaging Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc Documented ovulation by Luteinizing Hormone (LH) testing Follicle Stimulating Hormone (FSH) value >40 IU/L within 3 months prior to procedure Pelvic examination within 6 months prior to procedure Normal Pap smear Exclusion Criteria: Positive pregnancy test Uterine size > 20 weeks gestation Fibroids that are more than 50% submucosal Individual fibroids > 12cm in diameter, or total fibroid burden > 905cc Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid Fibroids situated in the cervix Abnormally large ovarian arteries Uterine pathology other than fibroids History of gynecologic malignancy Active pelvic infection or history of pelvic inflammatory disease Undiagnosed pelvic mass outside the uterus History of chemotherapy or radiation to the abdomen or pelvis Intra-Uterine Device (IUD) in position History of, or ongoing, hemolytic anemia Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment Anticoagulant therapy or known bleeding disorder Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks Received another investigational agent within past 12 weeks Compromised hematopoietic function Compromised hepatic function Compromised renal function BMI > 38 Claustrophobia Contraindication to angiography Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents Allergy to contrast agents Allergy to bovine collagen Patient desires to become pregnant, or does not agree to contraception during study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occlusin 500 microspheres<br>Uterine fibroid embolization | Device: Occlusin 500 Microspheres<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroid volume | Magnetic Resonance Imaging-determined fibroid volume | 6 months post-embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine volume | Magnetic Resonance Imaging-determined uterine volume | 1 month post-embolization | 
| Uterine volume | Magnetic Resonance Imaging-determined uterine volume | 6 months post-embolization | 
| Fibroid volume | Magnetic Resonance Imaging-determined fibroid volume | 1 month post-embolization | 
| Quality of Life Assessment | Uterine Fibroid Symptom Assessment by Questionnaire | 1 month post-embolization | 
| Quality of Life Assessment | Uterine Fibroid Symptom Assessment by Questionnaire | 6 month post-embolization |