Actively Enrolling:
EMBOLIZE
The EMBOLIZE trial is a first-of-its-kind prospective, randomized controlled trial studying the effects of ovarian vein embolization (OVE) in reducing pain in women experiencing chronic pain due to pelvic venous disease (PeVD).
About the EMBOLIZE Trial
SIR Foundation has launched a ground-breaking clinical trial exploring treatments for pelvic venous disorders, formerly referred to as Pelvic Congestion Syndrome (PCS). The EMBOLIZE trial is
a first-of-its-kind prospective, randomized controlled trial studying the effects of ovarian vein embolization (OVE) in reducing pain in
women experiencing venous-origin chronic pelvic pain (VO-CPP).
This trial is an investigator-initiated clinical trial sponsored by SIR Foundation and The VIVA Foundation, with support from Penumbra, Inc.
This trial is the first time SIR Foundation is leading a multi-organization collaboration to generate the data necessary to impact and improve patient care.
Why Participate in this Study?
Women living with pelvic pain often suffer in silence because of a lack of awareness of pelvic venous disease and the minimally invasive treatment options available. Dedicated to advancing innovative therapies that address a significant unmet need, this study will help provide clear evidence of the benefits of OVE and pelvic vein embolization (PVE) to help patients worldwide.
Objective
To determine efficacy, the study will compare changes in the patients’ pain scores from 4 weeks before treatment through 6 months post-treatment. Investigators will also evaluate other quality of life improvements, improvements in the pelvic varicose veins, and the changes in pain medication usage.
Study population
Study investigators at five sites are seeking women over the age of 18 who have either dilated ovarian vein or pelvic varicose veins.
Patient Follow Up
Follow-up will occur at 1, 3, and 6 months.
At the end of 6 months evaluation, participants who were randomized to control group will also be offered the opportunity to receive the OVE treatment.
What to Expect
Thank you for your interest in the EMBOLIZE Trial. Before moving forward in the screening and enrollment process, we encourage you to review the information below to better understand what participation may involve.
- Participants assigned to the control group will be offered embolization treatment at no cost after completion of the 6-month study period. Study-related treatment and procedure costs are covered as part of the clinical trial.
- Participation in the study will require 2 in-person visits at one of the participating study sites listed below. Travel, lodging, meals, and other transportation-related expenses are not covered as part of the trial.
- Individuals may not qualify if they are currently pregnant, have had prior pelvic embolization or venous stenting, have had a hysterectomy, or have another identified primary cause of pelvic pain.
- Additional eligibility criteria will be reviewed by the study team during the screening process.
Study Locations
Principal Investigator:
- Neil Khilnani, MD, FSIR
- Weill Cornell Medicine
- Gloria Salazar, MD, FSIR
- UNC School of Medicine
New York Locations
- Weill Cornell Medicine — (Now Recruiting)
- New York Presbyterian Hospital
- New York, New York, 10024
- Kim Scherer, DO
- Northwell Health — (Now Recruiting)
- Lake Success, New York, 11042
- Antonios Gasparis, MD, FACS
North Carolina Locations
- UNC Health — (Completed Recruiting)
- Chapel Hill, North Carolina, 27599
- Gloria Salazar, MD, FSIR
Learn More
Talk to your doctor to find out if the EMBOLIZE Trial is an option for you.
Visit the ClinicalTrials.gov website for more information
Study Sponsors
