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OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT03427671
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
IMBiotechnologies Ltd.

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

Condition or disease Intervention/treatment Phase
Uterine Fibroid Myoma Leiomyoma Device: Occlusin 500 Microspheres Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 2019

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.



Primary Outcome Measures :
  1. Fibroid volume [ Time Frame: 6 months post-embolization ]
    Magnetic Resonance Imaging-determined fibroid volume


Secondary Outcome Measures :
  1. Uterine volume [ Time Frame: 1 month post-embolization ]
    Magnetic Resonance Imaging-determined uterine volume

  2. Uterine volume [ Time Frame: 6 months post-embolization ]
    Magnetic Resonance Imaging-determined uterine volume

  3. Fibroid volume [ Time Frame: 1 month post-embolization ]
    Magnetic Resonance Imaging-determined fibroid volume

  4. Quality of Life Assessment [ Time Frame: 1 month post-embolization ]
    Uterine Fibroid Symptom Assessment by Questionnaire

  5. Quality of Life Assessment [ Time Frame: 6 month post-embolization ]
    Uterine Fibroid Symptom Assessment by Questionnaire


Other Outcome Measures:
  1. Ultrasound of Uterus [ Time Frame: 1 day post-embolization ]
    Qualitative assessment of uterus comparing baseline to post-embolization time points

  2. Ultrasound of Uterus [ Time Frame: 1 month post-embolization ]
    Qualitative assessment of uterus comparing baseline to post-embolization time points

  3. Ultrasound of Uterus [ Time Frame: 6 months post-embolization ]
    Qualitative assessment of uterus comparing baseline to post-embolization time points



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427671


Contacts
Contact: Richard Owen, MD 780-407-8365 rowen@ualberta.ca
Contact: Joanne McGoey, RN 780-407-8365 joanne.mcgoey@albertahealthservices.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Richard Owen, MD    780-407-8365    rowen@ualberta.ca   
Contact: Joanne McGoey, RN    780-407-8365    joanne.mcgoey@albertahealthservices.ca   
Sponsors and Collaborators
IMBiotechnologies Ltd.
Investigators
Principal Investigator: Richard Owen, MD University of Alberta

Responsible Party: IMBiotechnologies Ltd.
ClinicalTrials.gov Identifier: NCT03427671     History of Changes
Other Study ID Numbers: OCL500-P3-UFE-02
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases