Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-29 @ 5:39 PM
Study NCT ID:
NCT06168058
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2023-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analog Scale (VAS) for pelvic pain', 'timeFrame': 'Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up', 'description': "The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''"}], 'secondaryOutcomes': [{'measure': 'Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale', 'timeFrame': 'Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up', 'description': "The Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale assess how much a person hurts. The scale ranges from 1-5, defining 1 as ''no pain'' and 5 ''very severe pain.''"}, {'measure': 'Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale', 'timeFrame': 'Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measures assess an individual\'s physical, mental, and social health. The scale scores from from 5 to 1 with 5 = "Excellent" and 1= "Poor ".'}, {'measure': 'Change in Patient Global Impression of Change (PGIC)', 'timeFrame': '30, 90 and 180 day follow up', 'description': 'The self-report measure Patient Global Impression of Change (PGIC) reflects a patient\'s belief about the efficacy of treatment. PGIC is a 7 point scale with 1= "Very Much Improved" and 7= "Very Much Worse".'}, {'measure': 'Change in EuroQol five-dimension (EQ-5D) scale', 'timeFrame': 'Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up', 'description': 'The EuroQol five-dimension (EQ-5D) is a concise, generic measure of self-reported health at each visit. Patients will tick the one box that best describes their health on that day. This scale will measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The scale is numbered from 0 to 100. =100 means the best health the patient can imagine and 0 means the worst health the patient can imagine,.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pelvic Pain Syndrome', 'Pelvic Pain', 'Pelvic Varices', 'Pelvic Congestive Syndrome', 'Pelvic Pain Syndrome']}, 'descriptionModule': {'briefSummary': '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/pelvic vein embolization versus no embolization.', 'detailedDescription': 'The study is a randomized research trial of bilateral ovarian vein embolization (OVE) and pelvic vein embolization (PVE) in women with chronic pelvic pain (CPP), dilated and incompetent ovarian veins ≥6mm and pelvic varices (≥1 veins, \\>5 mm diameter) to assess for change in pain. Pain will be assessed by visual analog scale (VAS) and other relevant, validated quality of life metrics including the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 - Pain Intensity, Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health, Patient Global Impression of Change (PGIC) and EuroQol five-dimension (EQ 5D). The target population includes women age greater than or equal to 18 years who are pre-menopausal and have symptoms, and clinical and imaging findings corresponding to Pelvic Venous Disease (PeVD). Subjects will be randomized in a 1:1 fashion to embolization (treatment group) or venography only (control group). Follow-up will be assessed weekly and at 1, and 3 months and 6 months post procedure to assess for changes in quality of life in patients who receive ovarian/pelvic vein embolization versus no embolization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/pelvic varices as documented by TAUS or CT (≥1 veins, \\>5 mm diameter)\n * Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis\n\nExclusion Criteria:\n\n* Female \\<18 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/or Catheter Venography and deemed significant for exclusion by study patient review committee.\n* 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.\n* Presence of isolated extra-pelvic vulvar and/or 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 \\<30 mL/min)\n* Hemoglobin \\<8.0 g/dL, uncorrectable INR \\>3.0 or platelet count \\<75,000/microliter\n* Inability to provide informed consent or to comply with study assessments\n* Post thrombotic IVC, iliac or ovarian vein changes'}, 'identificationModule': {'nctId': 'NCT06168058', 'acronym': 'EMBOLIZE', 'briefTitle': 'Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '23-08026405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Transcatheter Venography', 'interventionNames': ['Diagnostic Test: Transcatheter Venography']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral Ovarian Vein Embolization', 'description': 'Transcatheter Venography plus Bilateral Ovarian Vein Embolization.', 'interventionNames': ['Diagnostic Test: Transcatheter Venography', 'Procedure: Bilateral ovarian vein embolization']}], 'interventions': [{'name': 'Transcatheter Venography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diagnostic Venography'], 'description': 'Venographic assessment of ovarian veins and internal iliac veins', 'armGroupLabels': ['Bilateral Ovarian Vein Embolization', 'Transcatheter Venography']}, {'name': 'Bilateral ovarian vein embolization', 'type': 'PROCEDURE', 'otherNames': ['Ovarian vein and pelvic vein embolization'], 'description': 'Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.', 'armGroupLabels': ['Bilateral Ovarian Vein Embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10024', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronald S Winokur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gloria Salazar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina (UNC)', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lake Washington Vascular', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'centralContacts': [{'name': 'Ronald S Winokur, MD', 'role': 'CONTACT', 'email': 'rsw9004@med.cornell.edu', 'phone': '646-962-9179'}, {'name': 'Sasha Garcia', 'role': 'CONTACT', 'email': 'sag2958@med.cornell.edu'}], 'overallOfficials': [{'name': 'Ronald S Winokur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Interventional Radiology Foundation', 'class': 'OTHER'}, {'name': 'VIVA Physicians', 'class': 'OTHER'}, {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}