IR UpFront Enrolling Now
EMBOLIZE trial for venous-origin chronic pelvic pain
The fi rst patients have been enrolled in EMBOLIZE, a randomized controlled trial of pelvic venous embolization for women with chronic pelvic pain of suspected venous origin at Weill Cornell Medicine/New York-Presbyterian Hospital in New York City.
The trial is funded by the IR community through the SIR Foundation, with support from the VIVA Foundation and with a generous unrestricted grant from Penumbra.
Encouraging case series have been published suggesting that pelvic venous embolization can substantially improve symptoms in appropriately selected women with venous origin chronic pelvic pain (VO-CPP). However, gynecologists and payers have been clear: broad acceptance and reliable coverage will require high-quality randomized data.
About the study
EMBOLIZE is a rigorous randomized, sham-controlled trial comparing pelvic venous embolization to a control procedure. This design helps separate true treatment eff ect from belief/placebo eff ects and is a critical step toward durable recognition and access to care.
Study investigators at fi ve sites are seeking women over the age of 18 who have either dilated ovarian or varicose pelvic veins.
To determine effi cacy, 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. Investigators will also evaluate other quality of life measures, improvements in the pelvic vein varices, and changes in pain medication usage.
Follow-up will occur at 1, 3 and 6 months and the duration of the trial will be 2 years.
irq.sirweb.org | 11 Why refer?
Referring eligible patients helps generate the evidence needed so gynecologists and payers can confi dently support this therapy for all future patients.
If you provide care for women with chronic, otherwise unexplained pelvic pain and imaging suggestive of pelvic venous insuffi ciency, please consider referring them for treatment in EMBOLIZE at Weill Cornell/NYP.
Please consider discussing participation in this trial with all study-eligible patients, even those who already have coverage for pelvic embolization, so researchers can generate the high- quality evidence needed to achieve universal coverage and broader acceptance as quickly as possible.
What’s the patient benefi t?
The study covers 100% of procedural and related care costs, allowing patients who lack insurance benefi ts for pelvic venous embolization to access treatment through the trial. In addition, all patients initially randomized to the control arm (diagnostic venography without embolization) will be off ered full study-funded embolization at the six-month unblinding point. In short, every patient referred who desires embolization will have the opportunity to receive it, with no copays or deductibles.
For referrals or more information, please contact:
Neil Khilnani, MD
nmkhilna@med.cornell.edu
or
Kim Scherer
kis2007@med.cornell.edu
on behalf of the EMBOLIZE Study PIs:
Gloria Salazar, MD
gloria_salazar@med.unc.edu
Ron Winokur, MD
rsw9004@med.cornell.edu
Learn more about EMBOLIZE at
ClinicalTrials.gov.
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