A new ground-breaking clinical trial exploring treatments for pelvic venous disorders has launched

SIR Foundation, The VIVA Foundation, and Penumbra, Inc., announce the start of the EMBOLIZE Trial

March 25, 2024—This article was featured in Endovascular Today.

A new prospective randomized controlled trial evaluating ovarian vein embolization (OVE) to reduce pain in women experiencing chronic pelvic pain due to pelvic venous disease (PeVD) was announced at the 2024 Society of Interventional Radiology (SIR) Meeting in Salt Lake City, Utah.

The EMBOLIZE trial is a multispecialty, investigator-initiated collaboration between the SIR Foundation and the VIVA Foundation, in partnership with Penumbra, Inc. The National Co-Principal Investigators are Ronald S. Winokur, MD, FSIR, Professor of Clinical Radiology at Weill Cornell Medicine, and Gloria Salazar, MD, FSIR, Associate Professor of Radiology at the University of North Carolina at Chapel Hill.

Patients who are over the age of 18 and have uterine, ovarian, or pelvic veins that are dilated and causing pain will be enrolled in the trial. EMBOLIZE will compare changes in pain score on a visual analog scale starting 4 weeks before treatment and continuing through 6 months postprocedure and evaluate outcomes of OVE for chronic pelvic pain of venous origin. Other quality-of-life improvements, pelvic vein varices, and changes in pain medication usage will also be evaluated. After the 6-month study period, patients in the control arm will be unblinded and have the option of receiving treatment with embolization.

EMBOLIZE investigators and representatives from SIR, VIVA, and Penumbra met with the media to discuss pelvic venous disease and the potential impact a randomized trial studying potential therapies could have, and there was an additional town hall session on the trial for SIR meeting attendees.

“Pelvic pain in women is extremely common, with massive impacts on quality of life,” said Dr. Winokur. “A randomized controlled trial evaluating outcomes after OVE and PVE will potentially have significant impacts on daily pelvic pain symptoms to effectively change the quality of life in this patient population.”

“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 Maureen P. Kohi, MD, FSIR, in the SIR press announcement. “This study will solidify the role of OVE in the treatment of women experiencing pain from pelvic venous disease and will also provide the evidence needed to ensure insurance coverage for these treatments.” Dr. Kohi is SIR Foundation Chair, a member of The VIVA Foundation Board of Directors, and Chair of the Department of Radiology at the University of North Carolina at Chapel Hill.

Dr. Salazar and EMBOLIZE investigator Neil Khilnani, MD, FSIR, expanded on the common scenario in which women do not have access to these procedures due to lack of payor coverage, pointing out that hysterectomy is often covered and offered as a potential option for these patients. Data from a randomized trial could help support the interventional option to payors, said Dr. Salazar, as well as raise public awareness of the condition and how it is diagnosed and potentially treated.

The panel acknowledged that pain is difficult to quantify and study. Dr. Khilnani, who is Professor of Clinical Radiology at Weill Cornell Vein Center, said that the EMBOLIZE trial plans to capture a variety of endpoints that are important to patients, with a specific focus on improving not just pain but quality of life. He noted that the trialists worked with gynecologists to better understand how such a study could be designed such that the data it produces will be meaningful to this community as well.

Dr. Kohi added that although EMBOLIZE is led by interventional radiologists, it is a multidisciplinary trial, with expert vascular surgeons represented in the steering committee and participating as site principal investigators.

Representing the industry sponsor at the media roundtable, Shruthi Narayan, Executive Vice President and General Manager of Penumbra’s interventional business, expressed the company’s enthusiasm in supporting the EMBOLIZE trial along with the SIR Foundation and VIVA Foundation in hopes of increasing awareness and opening up new treatment options for women with pelvic venous disease. In the SIR announcement, Penumbra’s Chief Medical Officer James F. Benenati, MD, FSIR, added, “Patients with pelvic venous disease have few treatment options available to them. 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.”

For patients suffering from pelvic venous disorder, please refer them to our Interventional Radiology team at (984) 974-8778.