SIR 2024: First-of-its-kind clinical trial announced for treatment of chronic pelvic pain
A new clinical trial testing treatments for chronic pelvic pain—which primarily afflicts women—was announced at the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting in Salt Lake City.
The Embolize Trial is first-of-its kind randomized clinical research, aiming to assess the efficacy of ovarian vein embolization (OVE) and pelvic vein embolization in reducing pain and resolving the condition. All participants are expected to have dilated uterine, ovarian or pelvic veins suspected of contributing to their chronic pain. Utilizing imaging and surveys, the study will track changes in pain scores from pre-treatment to six months post-treatment, while also assessing physical changes in the body and any reduction in pain medication usage.
The trial will bring together the SIR Foundation, the VIVA Foundation and healthcare technology company Penumbra, with Ronald S. Winokur, MD, from Weill Cornell Medicine, and Gloria Salazar, MD, from the University of North Carolina at Chapel Hill, serving as co-leads for the 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,” said SIR Foundation Chair Maureen P. Kohi, MD, a member of the VIVA Foundation Board of Directors and chair of the department of radiology at the University of North Carolina Chapel Hill said in a statement. “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.”
Embolize is currently recruiting women over 18 years of age to participate. The trial is expected to begin later this year.
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