Radiologists launch ‘groundbreaking’ clinical trial to assess new pain management method
Interventional radiologists are launching a “groundbreaking” clinical trial to assess a new approach to pain management, those involved announced Monday.
EMBOLIZE is a first-of-its-kind prospective, randomized control study on the use of ovarian and pelvic vein embolization. Such minimally invasive procedures involve closing off abnormal veins to relieve pain stemming from pelvic venous disease.
The Society of Interventional Radiology Foundation is helping lead the multisociety collaboration, with the VIVA (Vascular InterVentional Advances) Foundation also involved. Investigators are now seeking adult female participants who have dilated uterine, ovarian or pelvic veins that are causing chronic pain.
“Patients with pelvic venous disease have few treatment options available to them,” radiologist James F. Benenati, MD, chief medical officer at IR vendor Penumbra, which also is part of the trial, said in a March 25 announcement.
Interventional radiologists Ronald Winokur, MD, and Gloria Salazar, MD, with Weill Cornell Medicine and the University of North Carolina, respectively, are leading the trial as co-principal investigators. Their work will compare pain scores from four weeks before treatment through six months afterward. Winokur and Salazar also plan to assess changes in quality of life, pelvic vein varices and medication usage. Typically, pelvic venous disease impacts previously pregnant women who have experienced a backup of blood flow in the ovaries and pelvis, similar to varicose veins.
The trial launch was announced in conjunction with the Society of Interventional Radiology’s Annual Scientific Meeting, taking place through March 28 in Salt Lake City, Utah. SIR also released several news announcements highlighting:
- A new minimally invasive treatment option for prostate cancer that is demonstrating successful outcomes.
- Research showing that cryoablation is highly effective for breast cancer patients with large tumors.
- How hysterectomies can be avoided with earlier uterine artery embolization for postpartum hemorrhage.
- Winners of the SIR Foundation’s annual awards.
- Recipients of the society’s 2024 Gold Medals and details on this year’s Charles T. Dotter Lecture.