Vein Embolization for Chronic Pelvic Pain
(EMBOLIZE Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byRonald S Winokur, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.

Eligibility Criteria

This trial is for women over 18 with chronic pelvic pain linked to pelvic varicose veins, who've had the pain for more than 6 months. They should not be pregnant, planning pregnancy, or breastfeeding and must have a specific vein size on ultrasound or CT. Women post-menopause or those who've had previous vein treatments can't join.

Inclusion Criteria

Left or right ovarian vein diameter greater than or equal to 6 mm

I experience long-lasting pain after sex.

Absence of non-venous origin CPP as determined by Gynecology examination

+5 more

Exclusion Criteria

Known allergy to sclerosant, coil, stent or catheter components including nickel allergy

I have a major narrowing in my iliac vein.

I plan to become pregnant during the study.

+15 more

Participant Groups

The study tests if blocking off ovarian and pelvic veins (embolization) helps reduce chronic pelvic pain in women compared to just looking at the veins (venography). It's a randomized controlled trial which means participants are randomly assigned to one of these two approaches.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bilateral Ovarian Vein EmbolizationExperimental Treatment2 Interventions

Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Group II: Transcatheter VenographyPlacebo Group1 Intervention