NCT06168058 Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
| NCT ID | NCT06168058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Chronic Pelvic Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-08-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 1. 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 2. 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 3. 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 Criteria: * 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
Contact & Investigator
Ronald S Winokur, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06168058 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Chronic Pelvic Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06168058 currently recruiting?
Yes, NCT06168058 is actively recruiting participants. Contact the research team at rsw9004@med.cornell.edu for enrollment information.
Where is the NCT06168058 trial being conducted?
This trial is being conducted at New York, United States, Chapel Hill, United States, Bellevue, United States.
Who is sponsoring the NCT06168058 clinical trial?
NCT06168058 is sponsored by Weill Medical College of Cornell University. The principal investigator is Ronald S Winokur, MD at Weill Medical College of Cornell University. The trial plans to enroll 40 participants.