Status:
RECRUITING
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Society of Interventional Radiology Foundation
VIVA Physicians
Conditions:
Chronic Pelvic Pain Syndrome
Pelvic Pain
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
The study is a randomized research trial of bilateral ovarian vein embolization (OVE) and pelvic vein embolization (PVE) in women with chronic pelvic pain (CPP), dilated and incompetent ovarian veins ...
Eligibility Criteria
Inclusion
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
- Pain exacerbated by walking, standing or lifting
- Symptoms are at least partially alleviated by lying down
- Prolonged post-coital ache
- Absence of non-venous origin CPP as determined by Gynecology examination
- Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
- •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
- CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
- Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
- Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
- Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
Exclusion
- Female \<18 years of age
- Pregnancy (positive pregnancy test)
- Female subject who plans to become pregnant during study period
- Female subject who is actively breastfeeding
- Patient who is post-menopausal or anovulatory with hormone suppression
- History of prior hysterectomy
- Prior ovarian vein embolization or ovarian vein ligation
- Inability to tolerate endovascular procedure due to acute illness or general health
- Planned simultaneous treatment with nerve blocks during the duration of the study
- Laparoscopy or planned surgical intervention during the duration of the study
- Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
- Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
- Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
- Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
- Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
- Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
- Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
- Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
- Inability to provide informed consent or to comply with study assessments
- Post thrombotic IVC, iliac or ovarian vein changes
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06168058
Start Date
August 7 2025
End Date
June 1 2026
Last Update
September 2 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medicine
New York, New York, United States, 10024
2
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States, 27599
3
Lake Washington Vascular
Bellevue, Washington, United States, 98004