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EMBOLIZE Trial: Advancing Treatment for Chronic Pelvic Pain

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Neil Khilnani, MD

Weill Cornell Medicine

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Ronald Winokur, MD

New York Presbyterian Hospital

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Gloria Salazar, MD

University of North Carolina

Chronic pelvic pain (CPP) is a prevalent and often debilitating condition affecting up to 15% of women of childbearing age. A significant subset of these women may be affected by pelvic venous disease (PeVD), where dilated and incompetent veins in the pelvis lead to persistent discomfort. Despite its impact, PeVD remains under-diagnosed, and the data supporting treatment with embolization when reflux is the cause is considered are weak.

The EMBOLIZE trial is a multi-center, randomized controlled study designed to evaluate the efficacy of ovarian and pelvic vein embolization in alleviating venous origin CPP (VO-CPP). Led by Ronald Winokur. MD of Weill Cornell Medicine, this investigator-initiated trial is funded by a collaborative effort among the Society of Interventional Radiology (SIR) Foundation and The VIVA Foundation, with an unrestricted grant from Penumbra, Inc. (ClinicalTrials.gov ID: NCT06168058)

The study aims to enroll 40 premenopausal women aged 18 and older who exhibit symptoms of VO-CPP and have imaging-confirmed dilated pelvic and ovarian veins. Participants will be randomized into two groups: one undergoing diagnostic venography alone, and the other receiving venography followed by embolization of the affected veins. To ensure unbiased results, participants will be blinded to their group assignments for six months. The sample size was selected to ensure the study is adequately powered to detect a difference between the intervention and control groups.

The primary outcome focuses on changes in pain levels, measured weekly using the Visual Analog Scale (VAS), from 4 weeks before the procedure through 6 months post-treatment. Secondary outcomes include assessments of quality of life and functional status using validated instruments such as the EQ-5D-5L, PROMIS Pain Interference Short Form 3a, PROMIS Physical Function Short Form 10a, and the Patient Global Impression of Change (PGIC). Data collection is facilitated through weekly electronic surveys completed by participants via their mobile devices. (Figure 1).

Importantly, after the 6-month follow-up period, participants in the control group who continue to experience significant pain will be offered the embolization procedure at no cost (Figure 2).

By addressing previous research limitations—such as non-homogeneous patient populations, lack of control groups, and inconsistent use of outcome measures—the EMBOLIZE trial seeks to provide robust evidence on the effectiveness of embolization for VO-CPP. Findings from this study have the potential to inform clinical practice and influence insurance coverage decisions, ultimately improving access to care for women suffering from PeVD.

The EMBOLIZE Trial funds all care provided in the study, including the cross-over to embolization for the women originally assigned to the sham procedure group. Therefore, this study will allow access to care for women referred to this study in whom insurance coverage is currently not available. Please consider referring patients to this study by contacting the study investigators using the QR code in Figure 2.

Figure 1: A visual representation of the EMBOLIZE study design and participant flow utilizing a CONSORT diagram

Figure 2. QR code to the ClinicalTrials.gov listing for this study, which includes contact information to refer patients to the EMBOLIZE Trial

A Message from the AVF President

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Joseph Raffetto, MD

Dear Friends, Members, and Colleagues,

It is with great honor that I have been elected as your 38th American Venous Forum President. I reflect to when I attended my first AVF meeting in Dana Point, CA, in 1999 and presented my basic science work. I was immediately impressed by those representing the AVF, the meeting organizers, the scientific content, and the diverse knowledge base from the experts. The members, both new and senior alike, were incredibly welcoming and kind. I remember meeting fantastic mentors such as Professor Villavicencio, who told me in my early career that the AVF has great potential and its success will come from its membership. He was a wonderful mentor and person, and his message resonates with me as I step into this new role, as I hope it does with you as our members.

A society is defined by its membership, leadership, administrative support, core values, mission, accomplishments, and dedication to future goals and achievements. The AVF has become a recognized world leader in scientific distribution and provision of clinical practice guidelines for clinicians of all backgrounds who care for patients with chronic venous and lymphatic disorders. I have seen incredible positive change through the last quarter century as a member of the AVF. I have continually noticed the excitement, passion, and drive our organization has for increasing education, community outreach, partnerships, research, policy, international community engagement, and industry relationships. Each area has a foundation and purpose to provide continued and improved patient care. Our meetings have become integrated with Advanced Practice Professionals, Physicians-in-Training, Early Career Clinical Practitioners, Medical and Nursing Students, and our Senior Members. Each group has a role and is recognized for their contributions, accomplishments, and mentorship. Together we bring a wealth of knowledge that is shared during our plenary, poster, and special sessions, as well as our discussions and networking opportunities. Our leadership, committees, and administration are the framework for our yearly societal operations and direct excellence in our activities through webinars, special meetings for our early career practitioners, newsletter updates, and dedicated sessions to enhance the benefit of our educational offerings. As our membership grows, so does our commitment to excellence and our future leaders.

A strength of the AVF mission is that we strive to provide opportunities to our members. Members can participate in many functions and on many committees within the AVF. Our leadership stands by for anyone interested to inform and gain insight on committee functions, outreach programs, participation in webinars, and annual meeting opportunities. We encourage you to participate, present ideas, and engage with the AVF and our core values, as we cherish our members’ unique qualities and experiences that collectively enhance our mission toward continued education and patient care.

Our AVF Annual Meeting in 2026 will be in Denver, Colorado. Our committees and leadership are working diligently to make the AVF 2026 program meet the expectations and educational needs of all members and guests. The program will provide comprehensive plenary sessions including presentations, group discussions, and audience participation segments for all to gain knowledge from. We encourage every member and non-member to share their work via abstract submission. Our Education Committee has several journal clubs, special topic sessions, and “Ask the Experts” discussions that will be announced throughout the year for all to participate in virtually. Our International Committee is working on our yearly activities, including webinars, specialty sessions, and a wonderful International Session planned for our annual meeting. There are many highlights at AVF 2026 and we invite all to share their knowledge, ask questions, and learn from each other. There are always differences in how we practice, but we will always be unified in our goal to provide the best care that we can to our patients. We are a family, and our strength lies in the many collaborations and partnerships that we develop and see to fruition. We look forward to your yearly participation and attendance at our AVF 2026 Annual Meeting to enjoy educational opportunities, fruitful discussions, and the beautiful scenery of the Rocky Mountains.

I would like to thank you all for entrusting me with this role as your next American Venous Forum President. I am genuinely grateful for your commitment to and investment in the AVF and I look forward to meeting as many of you as I can during this year and next.  Thank you.

Leadership Corner: Ruth L. Bush, MD’s Presidential Address

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Jillian Norbut

AVF Communications Intern

This past February, the American Venous Forum hosted its 37th annual meeting in Atlanta, Georgia. This meeting provided opportunities for members and non-members alike, such as educational presentations, research highlights, and chances to network with fellow professionals. These programming events included a inspiring speech from Ruth L. Bush,MD, JD, MPH, AVF’s 2024-2025 President, focusing on how AVF has moved from “good to great” in its past several years as an organization.

Dr Bush’s presentation centered on the 2001 book Good to Great, by James C. Collins. Its contents focus on the titular theme of taking a company or organization from mediocrity to excellence. Collins visualized this idea by utilizing a pyramid with five levels, with each one denoting a different level of professional strength. Dr Bush touched on all levels within her talk, with a specific focus on Level 5, Executive Leadership. She explained that for an organization to reach an effective Level 5 leadership standard it must employ a careful balance of personal humility and strong professional will, which the AVF has achieved over time with its efforts to improve patient care, globalize its network, and stay true to its core values.

Dr. Bush went on to highlight specific achievements within the AVF that have led the organization to this Level 5 leadership status. She began by recognizing the ever-changing and adaptable organizational structure of the AVF, commending CEO John Forbes and Associate Director Amy Murrin as visionaries who have shifted to a new leadership style that has guided and motivated the entire organization. She recognized their coordinated efforts to strategize and promote AVF and our educational opportunities. Additionally, Dr Bush acclaimed the structure of the AVF committees as a prime example of Level 5 leadership and what she denoted as the 5 C’s of change management: communication, commitment, culture, capability, and coordination.

Additionally, Dr. Bush explained how the AVF has embodied both professional will and humility through its efforts to invite members to give back to the community. She recognized the new committee, the Venous Access and Equity Committee, which started as a task force two years ago and has since grown. She also acknowledged all of the good that has come from AVF’s Day of Service, which promoted health equity and helped improve healthcare for local communities in Tampa, as well as acknowledging the donations and scholarships AVF has awarded over the past year. Dr Bush then asked for a call to action, asking members and meeting attendees to surpass their donation goal for the upcoming year. She concluded her talk by reaffirming AVF’s embodiment of Level 5 leadership, describing it as “ambitious and forward-thinking, but with humility and a giving spirit.”

Join us at the Vein & Lymphatic Summit on July 18-19, 2025

Monika Gloviczki, MD, PhD

Peter Gloviczki, MD, PhD

Symposium Chair

The 2nd Vein and Lymphatic Summit (VLS2025), organized jointly with the American Venous Forum, is a live, online Continuing Medical Education (CME) symposium scheduled for July 18-19, 2025.  This unique international meeting brings together a world-class faculty of 43 international experts from 5 continents to discuss the latest advances and controversies in the multidisciplinary management of acute and chronic venous disease, lymphedema, lipedema, and wound care.

During the 2-day program, 10 sessions will include 50 rapid-fire presentations and expert panel discussions, providing ample opportunity to debate important topics or answer burning questions submitted live from the audience. This on-line conference uses an exclusive digital platform: the presentations and the industry exhibits will take place in a virtual conference center where the participants can “walk around” and listen to lectures or panel discussions in the virtual conference room or enter the exhibit hall to meet the exhibitors and chat on specific products with our industry partners.   All this, from the comfort of our home or office, using a desktop computer, a laptop, I-phone, or Android.

The main topics include evaluation and treatment of chronic venous disease, thermal and non-thermal ablations, foam and liquid sclerotherapy, interventional and local treatment of venous ulcers, venous disease and the diabetic foot, post-thrombotic syndrome, stenting of deep veins, mechanical thrombectomy for acute deep vein thrombosis, the pros and cons of drug and compression therapy, the management of lymphedema and lipedema, and critical issues affecting our outpatient practice.

REGISTRATION IS FREE FOR ALL ATTENDEES!

You will receive up to 15 AMA PRA Category 1 Credit(s). category one CME credit.

We are looking forward to your participation, please register at https://vls2025.lerexpo.com/

See you on July 18-19, 2025.

Submit an abstract for AVF 2026

Misaki Kiguchi, MD; Co-Chair, AVF Program Committee

The annual meeting of the American Venous Forum will be held on March 1-4, 2026. The 2026 meeting theme is “Solutions Through Science,” highlighting the evidence behind cutting-edge techniques. In addition, a special session will focus on the creation and execution of Pulmonary Embolism Response Teams (PERT). The Doctors’ Lounge, an intimate, case-based discussion session will have an encore session in 2026. Please consider submitting your abstract and join us and our AVF President Joseph Raffetto in what will be an informative and exciting four days in Denver.

Submit today!