[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528998":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":46,"responsibleParty":86,"collaborators":88,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":11,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcatheter Venography","SHAM_COMPARATOR",null,[13],"Diagnostic Test: Transcatheter Venography",{"label":15,"type":16,"description":17,"interventionNames":18},"Bilateral Ovarian Vein Embolization","EXPERIMENTAL","Transcatheter Venography plus Bilateral Ovarian Vein Embolization.",[13,19],"Procedure: Bilateral ovarian vein embolization",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Venographic assessment of ovarian veins and internal iliac veins",[15,9],[26],"Diagnostic Venography",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Bilateral ovarian vein embolization","Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.",[15],[33],"Ovarian vein and pelvic vein embolization",[35],{"name":36,"affiliation":5,"role":37},"Ronald S Winokur, MD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":11,"email":42},"CONTACT","646-962-9179","rsw9004@med.cornell.edu",{"name":44,"role":40,"phone":11,"phoneExt":11,"email":45},"Sasha Garcia","sag2958@med.cornell.edu",[47,62,75],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Weill Cornell Medicine","RECRUITING","New York","10024","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-74.00597,40.71427,{"lat":58,"lon":57},[61],{"name":36,"role":37,"phone":11,"phoneExt":11,"email":11},{"facility":63,"status":49,"city":64,"state":65,"zip":66,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"UNC School of Medicine","Chapel Hill","North Carolina","27599",{"type":55,"coordinates":68},[69,70],-79.05584,35.9132,{"lat":70,"lon":69},[73],{"name":74,"role":37,"phone":11,"phoneExt":11,"email":11},"Gloria Salazar, MD",{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":85,"contacts":11},"Lake Washington Vascular","WITHDRAWN","Bellevue","Washington","98004",{"type":55,"coordinates":82},[83,84],-122.20068,47.61038,{"lat":84,"lon":83},{"type":87,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[89,91,93],{"name":90,"class":6},"Society of Interventional Radiology Foundation",{"name":92,"class":6},"VIVA Physicians",{"name":94,"class":95},"Penumbra Inc.","INDUSTRY","100528998","trial-of-ovarian-vein-and-pelvic-vein-embolization-in-women-with-chronic-pelvic-pain-and-pelvic-varices-100528998",false,"NCT06168058","Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices","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","EMBOLIZE","Inclusion Criteria:\n\n1. 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:\n\n   * Pain exacerbated by walking, standing or lifting\n   * Symptoms are at least partially alleviated by lying down\n   * Prolonged post-coital ache\n   * Absence of non-venous origin CPP as determined by Gynecology examination\n2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:\n\n   •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT\n3. CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors\n\n   * Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT\n   * Presence of intrabdominal\u002Fpelvic varices as documented by TAUS or CT (≥1 veins, \\>5 mm diameter)\n   * Presence of venous reflux in ovarian and\u002For internal iliac veins without evidence of hemodynamically significant stenosis\n\nExclusion Criteria:\n\n* Female \\\u003C18 years of age\n* Pregnancy (positive pregnancy test)\n* Female subject who plans to become pregnant during study period\n* Female subject who is actively breastfeeding\n* Patient who is post-menopausal or anovulatory with hormone suppression\n* History of prior hysterectomy\n* Prior ovarian vein embolization or ovarian vein ligation\n* Inability to tolerate endovascular procedure due to acute illness or general health\n* Planned simultaneous treatment with nerve blocks during the duration of the study\n* Laparoscopy or planned surgical intervention during the duration of the study\n* Known allergy to sclerosant, coil, stent or catheter components including nickel allergy\n* Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and\u002For Catheter Venography and deemed significant for exclusion by study patient review committee.\n* Any renal vein stenosis with resultant renal hilar varices\u002Fcollaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and\u002For Diagnostic Venography and deemed significant for exclusion by study patient review committee.\n* Presence of isolated extra-pelvic vulvar and\u002For lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.\n* Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)\n* Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication\n* Severe renal impairment (on chronic dialysis or estimated GFR \\\u003C30 mL\u002Fmin)\n* Hemoglobin \\\u003C8.0 g\u002FdL, uncorrectable INR \\>3.0 or platelet count \\\u003C75,000\u002Fmicroliter\n* Inability to provide informed consent or to comply with study assessments\n* Post thrombotic IVC, iliac or ovarian vein changes",true,"FEMALE","18 Years","75 Years",{"count":109,"type":110},40,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.\n\nThe data gathered will assist in addressing changes in quality of life in patients who have ovarian\u002Fpelvic vein embolization versus no embolization.",[116,117,118,119,120],"Chronic Pelvic Pain Syndrome","Pelvic Pain","Pelvic Varices","Pelvic Congestive Syndrome","Pelvic Pain Syndrome","2026-03-11",{"date":123,"type":124},"2026-03-13","ACTUAL",{"date":126,"type":124},"2025-08-07",{"date":128,"type":110},"2027-06",{"name":5,"class":6},3]