OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

NCT03427671 | Completed

• 1 other identifier: OCL500-P3-UFE-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Fibroid; Myoma; Leiomyoma

Outcome Measures

Primary Outcomes (1)

• Fibroid volume

  Magnetic Resonance Imaging-determined fibroid volume

  6 months post-embolization

Secondary Outcomes (5)

• Uterine volume

  1 month post-embolization

• Uterine volume

  6 months post-embolization

• Fibroid volume

  1 month post-embolization

• Quality of Life Assessment

  1 month post-embolization

• Quality of Life Assessment

  6 month post-embolization

Other Outcomes (3)

• Ultrasound of Uterus

  1 day post-embolization

• Ultrasound of Uterus

  1 month post-embolization

• Ultrasound of Uterus

  6 months post-embolization

Study Arms (1)

Occlusin 500 microspheres

EXPERIMENTAL

Uterine fibroid embolization

Device: Occlusin 500 Microspheres

Interventions

Occlusin 500 Microspheres DEVICE

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.

Occlusin 500 microspheres

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IMBiotechnologies Ltd.: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Leiomyoma; Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Richard Owen, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 9, 2018
• Study Start: January 17, 2018
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)