AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 75 YearsFemaleWeill Medical College of Cornell University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Presence of venous origin chronic pelvic pain for greater than 6 months (VAS โ‰ฅ7 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: โ€ขS2V2PBGV,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 (โ‰ฅ1 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
๐Ÿ’Š

What it tests

  • Transcatheter Venography
  • Bilateral ovarian vein embolization
๐Ÿ“

Where

5 sites
University of Kansas Medical Center
Kansas City, United States
Northwell Health Physician Partners Vascular Surgery
New Hyde Park, United States
Weill Cornell Medicine
New York, United States
UNC School of Medicine
Chapel Hill, United States
Lake Washington Vascular
Bellevue, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy