Ovarian and pelvic vein embolization for women with chronic pelvic pain and pelvic varices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled trial that assigns eligible premenopausal women 1:1 to bilateral ovarian and pelvic vein embolization versus diagnostic venography only. Eligible participants have at least six months of venous-origin pelvic pain with imaging evidence of dilated ovarian veins (≥6 mm) and pelvic varices (≥5 mm). Pain and quality of life are measured using VAS, PROMIS pain and global health scales, PGIC, and EQ-5D, with follow-up weekly and at 1, 3, and 6 months after the procedure. The trial is being run at multiple U.S. centers including Weill Cornell Medicine, UNC School of Medicine, and Lake Washington Vascular.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Northwell Health Physician Partners Vascular Surgery
  New Hyde Park, New York, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting
• UNC School of Medicine
  Chapel Hill, North Carolina, United States Recruiting
• Lake Washington Vascular
  Bellevue, Washington, United States Withdrawn

Study contacts

• Principal investigator: Neil M Khilnani, MD — Weill Medical College of Cornell University
• Study coordinator: Neil M Khilnani, MD
• Email: EMBOLIZE@med.cornell.edu
• Phone: 646-962-9179

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.