RECRUITING

Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

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Conditions

Chronic Pelvic Pain SyndromePelvic PainPelvic VaricesPelvic Congestive SyndromePelvic Pain Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Controlled, Single-Blinded, Parallel-Group Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE) Trial

Quick Facts

Study Start:2025-08-07
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06168058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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:
  2. * Pain exacerbated by walking, standing or lifting
  3. * Symptoms are at least partially alleviated by lying down
  4. * Prolonged post-coital ache
  5. * Absence of non-venous origin CPP as determined by Gynecology examination
  6. 2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
  7. 3. CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
  8. * Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
  9. * Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
  10. * Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
  1. * Female \<18 years of age
  2. * Pregnancy (positive pregnancy test)
  3. * Female subject who plans to become pregnant during study period
  4. * Female subject who is actively breastfeeding
  5. * Patient who is post-menopausal or anovulatory with hormone suppression
  6. * History of prior hysterectomy
  7. * Prior ovarian vein embolization or ovarian vein ligation
  8. * Inability to tolerate endovascular procedure due to acute illness or general health
  9. * Planned simultaneous treatment with nerve blocks during the duration of the study
  10. * Laparoscopy or planned surgical intervention during the duration of the study
  11. * Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
  12. * 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.
  13. * 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.
  14. * Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
  15. * Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
  16. * Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
  17. * Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
  18. * Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
  19. * Inability to provide informed consent or to comply with study assessments
  20. * Post thrombotic IVC, iliac or ovarian vein changes

Contacts and Locations

Study Contact

Ronald S Winokur, MD
CONTACT
646-962-9179
rsw9004@med.cornell.edu
Sasha Garcia
CONTACT
sag2958@med.cornell.edu

Principal Investigator

Ronald S Winokur, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10024
United States
University of North Carolina (UNC)
Chapel Hill, North Carolina, 27599
United States
Lake Washington Vascular
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Ronald S Winokur, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-07
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pelvic Pain Syndrome
  • Pelvic Pain
  • Pelvic Varices
  • Pelvic Congestive Syndrome
  • Pelvic Pain Syndrome