EMBOLIZE
Randomized Controlled Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE)
SIR Foundation has launched a ground-breaking clinical trial exploring treatments for pelvic venous disorders. 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).
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.
The VIVA Foundation and Penumbra Inc. among the supporters of EMBOLIZE
About the trial
Study population: Study investigators at five sites are seeking women over the age 18 who have either dilated ovarian vein or varicose pelvic veins.
Objective: To determine efficacy, the study will compare changes in the patients’ pain scores on a visual analog scale from 4 weeks before treatment through 6 months post-treatment. Investigators will also evaluate other quality of life improvements, improvements in the pelvic vein varices, and the changes in pain medication usage.
Principal Investigators: Ronald S. Winokur, MD, FSIR from Weill Cornell Medicine and Gloria Salazar, MD, FSIR from the University of North Carolina.
Follow-up and duration: Follow-up will occur at 1, 3 and 6 months and the duration of the trial will be 2 years.
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If you are a patient interested in potentially participating in the EMBOLIZE study, please click on or scan the QR code below to fill out the interest form.