Status:
COMPLETED
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
Lead Sponsor:
IMBiotechnologies Ltd.
Conditions:
Uterine Fibroid
Myoma
Eligibility:
FEMALE
Phase:
NA
Brief Summary
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03427671
Start Date
January 17 2018
End Date
September 3 2019
Last Update
September 12 2019
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7