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OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

Primary Purpose

Uterine Fibroid, Myoma, Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Occlusin 500 Microspheres
Sponsored by
IMBiotechnologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alberta Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Occlusin 500 microspheres

Arm Description

Uterine fibroid embolization

Outcomes

Primary Outcome Measures

Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume

Secondary Outcome Measures

Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire

Full Information

First Posted
February 4, 2018
Last Updated
September 11, 2019
Sponsor
IMBiotechnologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03427671
Brief Title
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IMBiotechnologies Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid, Myoma, Leiomyoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occlusin 500 microspheres
Arm Type
Experimental
Arm Description
Uterine fibroid embolization
Intervention Type
Device
Intervention Name(s)
Occlusin 500 Microspheres
Intervention Description
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 Measure Information:
Title
Fibroid volume
Description
Magnetic Resonance Imaging-determined fibroid volume
Time Frame
6 months post-embolization
Secondary Outcome Measure Information:
Title
Uterine volume
Description
Magnetic Resonance Imaging-determined uterine volume
Time Frame
1 month post-embolization
Title
Uterine volume
Description
Magnetic Resonance Imaging-determined uterine volume
Time Frame
6 months post-embolization
Title
Fibroid volume
Description
Magnetic Resonance Imaging-determined fibroid volume
Time Frame
1 month post-embolization
Title
Quality of Life Assessment
Description
Uterine Fibroid Symptom Assessment by Questionnaire
Time Frame
1 month post-embolization
Title
Quality of Life Assessment
Description
Uterine Fibroid Symptom Assessment by Questionnaire
Time Frame
6 month post-embolization
Other Pre-specified Outcome Measures:
Title
Ultrasound of Uterus
Description
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time Frame
1 day post-embolization
Title
Ultrasound of Uterus
Description
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time Frame
1 month post-embolization
Title
Ultrasound of Uterus
Description
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time Frame
6 months post-embolization

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Owen, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

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