OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

Leiomyoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427671
• Other study ID #: OCL500-P3-UFE-02
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: September 3, 2019

Study information

• Verified date: September 2019
• Source: IMBiotechnologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma
• Uterine Fibroid

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
IMBiotechnologies Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	1 day post-embolization
Other	Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	1 month post-embolization
Other	Ultrasound of Uterus	Qualitative assessment of uterus comparing baseline to post-embolization time points	6 months post-embolization
Primary	Fibroid volume	Magnetic Resonance Imaging-determined fibroid volume	6 months post-embolization
Secondary	Uterine volume	Magnetic Resonance Imaging-determined uterine volume	1 month post-embolization
Secondary	Uterine volume	Magnetic Resonance Imaging-determined uterine volume	6 months post-embolization
Secondary	Fibroid volume	Magnetic Resonance Imaging-determined fibroid volume	1 month post-embolization
Secondary	Quality of Life Assessment	Uterine Fibroid Symptom Assessment by Questionnaire	1 month post-embolization
Secondary	Quality of Life Assessment	Uterine Fibroid Symptom Assessment by Questionnaire	6 month post-embolization