Launch of EMBOLIZE Clinical Trial Is First-of-its-kind Study to Explore Treatment for Pelvic Venous Disorders

The Society of Interventional Radiology (SIR) Foundation, The VIVA Foundation and Penumbra, Inc. officially launched the EMBOLIZE trial, a ground-breaking prospective, randomized controlled trial studying the effects of ovarian and pelvic vein embolization (OVE) in reducing pain in women experiencing chronic 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.”