SIR Foundation, The VIVA Foundation, and Penumbra, Inc., announce the start of the EMBOLIZE Trial
SALT LAKE CITY (March 25, 2024)—The Society of Interventional Radiology (SIR) Foundation, The VIVA Foundation and Penumbra, Inc., today announced the launch of the EMBOLIZE trial, a first-of-its-kind prospective, randomized controlled trial studying the effects of ovarian vein embolization (OVE) and pelvic vein embolization in reducing pain in women experiencing chronic pelvic pain due to pelvic venous disease (PeVD).
“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,” said SIR Foundation Chair Maureen P. Kohi, M.D., FSIR, a member of The VIVA Foundation Board of Directors and an interventional radiologist and chair of the department of radiology at the University of North Carolina Chapel Hill. “This study will solidify the role of OVE in the treatment of women experiencing pain from pelvic venous disease and will also provide evidence needed to ensure insurance coverage for these treatments.”
This trial is a multi-society collaboration between SIR Foundation and The VIVA Foundation, in partnership with Penumbra, Inc. An investigator-initiated clinical trial, EMBOLIZE will be led by Ronald S. Winokur, M.D., FSIR, professor of clinical radiology at Weill Cornell Medicine, and Gloria Salazar, M.D., FSIR, associate professor of radiology at the University of North Carolina at Chapel Hill. Both will serve as the national co-principal investigators.
The study investigators are seeking women over the age 18 who have dilated uterine, ovarian vein or pelvic veins that are causing chronic pain. 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 to evaluate the outcome of vein-directed intervention for venous origin chronic pelvic pain. Investigators will also evaluate other quality of life improvements, improvements in the pelvic vein varices, and changes in pain medication usage.
PeVD occurs when enlarged veins develop in the pelvis surrounding the uterus or ovaries. This can lead to severe chronic pelvic pain. PeVD usually affects women who have previously been pregnant and have experienced a backup of blood flow in the ovarian and pelvic veins much like varicose veins in the legs.
“Patients with pelvic venous disease have few treatment options available to them,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra, Inc. “Dedicated to advancing innovative therapies that address a significant unmet need, Penumbra’s support of this study will help provide clear evidence of the benefits of OVE and PVE to help patients worldwide.”
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About SIR Foundation
SIR Foundation fosters research and education in interventional radiology for the purposes of advancing scientific knowledge, increasing the number of skilled investigators in interventional radiology and developing innovative therapies that lead to improved patient care and quality of life. For more than 30 years, SIR Foundation has funded grants and conducted research panels, driving research and innovation to build the future of interventional radiology and support promising interventional research. Visit sirfoundation.org.
About SIR
The Society of Interventional Radiology is a nonprofit, professional medical society representing more than 8,000 practicing interventional radiology physicians, trainees, students, scientists and clinical associates, dedicated to improving patient care through the limitless potential of image-guided therapies. SIR’s members work in a variety of settings and at different professional levels—from medical students and residents to university faculty and private practice physicians. Visit sirweb.org and connect on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn.
About The VIVA Foundation
The VIVA Foundation is a not-for-profit organization committed to improving patient outcomes by advancing the field of vascular medicine and intervention through collaborative education, advocacy, and targeted research. In addition to hosting VIVA (Vascular InterVentional Advances) and The VEINS (Venous Endovascular INterventional Strategies), two annual multidisciplinary vascular education conferences for physicians and healthcare professionals, The VIVA Foundation also presents the Vascular Leaders Forum and collaborates with other industry-leading groups to move the field forward. Visit viva-foundation.org for more information.
