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OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

Sponsor
IMBiotechnologies Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03427671
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
19.5
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Occlusin 500 Microspheres
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
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
Actual Study Start Date :
Jan 17, 2018
Actual Primary Completion Date :
Sep 3, 2019
Actual Study Completion Date :
Sep 3, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Fibroid volume [6 months post-embolization]

    Magnetic Resonance Imaging-determined fibroid volume

Secondary Outcome Measures

  1. Uterine volume [1 month post-embolization]

    Magnetic Resonance Imaging-determined uterine volume

  2. Uterine volume [6 months post-embolization]

    Magnetic Resonance Imaging-determined uterine volume

  3. Fibroid volume [1 month post-embolization]

    Magnetic Resonance Imaging-determined fibroid volume

  4. Quality of Life Assessment [1 month post-embolization]

    Uterine Fibroid Symptom Assessment by Questionnaire

  5. Quality of Life Assessment [6 month post-embolization]

    Uterine Fibroid Symptom Assessment by Questionnaire

Other Outcome Measures

  1. Ultrasound of Uterus [1 day post-embolization]

    Qualitative assessment of uterus comparing baseline to post-embolization time points

  2. Ultrasound of Uterus [1 month post-embolization]

    Qualitative assessment of uterus comparing baseline to post-embolization time points

  3. Ultrasound of Uterus [6 months post-embolization]

    Qualitative assessment of uterus comparing baseline to post-embolization time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7

Sponsors and Collaborators

  • IMBiotechnologies Ltd.

Investigators

  • Principal Investigator: Richard Owen, MD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IMBiotechnologies Ltd.
ClinicalTrials.gov Identifier:
NCT03427671
Other Study ID Numbers:
  • OCL500-P3-UFE-02
First Posted:
Feb 9, 2018
Last Update Posted:
Sep 12, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Sep 12, 2019