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

• ClinicalTrials.gov Identifier: NCT06168058
• Recruitment Status: Not yet recruiting
• First Posted: December 13, 2023
• Last Update Posted: May 8, 2024
• Sponsor: Weill Medical College of Cornell University
• Collaborators: Society of Interventional Radiology Foundation; VIVA Physicians; Penumbra Inc.
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pelvic Pain Syndrome; Pelvic Pain; Pelvic Varices; Pelvic Congestive Syndrome; Pelvic Pain Syndrome	Diagnostic Test: Transcatheter Venography; Procedure: Bilateral ovarian vein embolization	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: June 2024
• Estimated Primary Completion Date: January 2026
• Estimated Study Completion Date: June 2026

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Transcatheter Venography	Diagnostic Test: Transcatheter Venography; Venographic assessment of ovarian veins and internal iliac veins; Other Name: Diagnostic Venography
Experimental: Bilateral Ovarian Vein Embolization; Transcatheter Venography plus Bilateral Ovarian Vein Embolization.	Diagnostic Test: Transcatheter Venography; Venographic assessment of ovarian veins and internal iliac veins; Other Name: Diagnostic Venography; Procedure: Bilateral ovarian vein embolization; Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.; Other Name: Ovarian vein and pelvic vein embolization

Outcome Measures

Primary Outcome Measures :

1. Change in Visual Analog Scale (VAS) for pelvic pain [ Time Frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up ]
   The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''

Secondary Outcome Measures :

1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale [ Time Frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up ]
   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.''
2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale [ Time Frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up ]
   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 ".
3. Change in Patient Global Impression of Change (PGIC) [ Time Frame: 30, 90 and 180 day follow up ]
   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".
4. Change in EuroQol five-dimension (EQ-5D) scale [ Time Frame: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up ]
   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,.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7) 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
• Symptoms-Varices-Pathophysiology Classification: S2V2PBGV,R,NT, S2V2PRGV,R,NT, S2V2PLGV,R,NT
• Left or right ovarian vein diameter greater than or equal to 6 mm
• Presence of pelvic varices as documented by transabdominal ultrasound or CT (≥1 veins, >5 mm diameter)

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
• 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
• Significant iliac vein stenosis defined as >61% area reduction as determined by the investigator at the time on pelvic DUS or CT venogram prior to study procedure
• Significant renal vein stenosis with resultant hilar varices and lumbar collaterals as determined by the investigator at the time of venography
• Serious medical condition 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

Contacts and Locations

Contacts

Contact: Ronald S Winokur, MD; 646-962-9179; rsw9004@med.cornell.edu

Contact: Jincy Koshy, MHA; 646-962-2964; jlk4004@med.cornell.edu

Locations

United States, Illinois

Northwestern Medicine

Chicago, Illinois, United States, 60611

Principal Investigator: Ramona Gupta, MD

Sub-Investigator: Kush Desai, MD

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10024

Principal Investigator: Ronald S Winokur, MD

United States, North Carolina

University of North Carolina (UNC)

Chapel Hill, North Carolina, United States, 27599

Principal Investigator: Gloria Salazar, MD

United States, Washington

Lake Washington Vascular

Bellevue, Washington, United States, 98004

Principal Investigator: Kathleen Gibson, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Society of Interventional Radiology Foundation

VIVA Physicians

Penumbra Inc.

Investigators

• Principal Investigator: Ronald S Winokur, MD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT06168058
• Other Study ID Numbers: 23-08026405
• First Posted: December 13, 2023
• Last Update Posted: May 8, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Varicose Veins; Syndrome; Pelvic Pain; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases