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

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

Study Overview

• Status: Completed
• Conditions: Myoma; Uterine Fibroid; Leiomyoma
• Intervention / Treatment: Device: Occlusin 500 Microspheres

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlusin 500 microspheres; Uterine fibroid embolization	Device: Occlusin 500 Microspheres; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	1 day post-embolization
Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	1 month post-embolization
Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	6 months post-embolization

Collaborators and Investigators

• Sponsor: IMBiotechnologies Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: February 4, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: OCL500-P3-UFE-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No