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

NCT06168058 | Recruiting DMC FDA Device

• 1 other identifier: 23-08026405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Pelvic Pain Syndrome; Pelvic Pain; Pelvic Varices; Pelvic Congestive Syndrome; Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) for pelvic pain

  The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''

  Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

Secondary Outcomes (4)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale

  Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale

  Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

• Change in Patient Global Impression of Change (PGIC)

  30, 90 and 180 day follow up

• Change in EuroQol five-dimension (EQ-5D) scale

  Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up

Study Arms (2)

Transcatheter Venography

SHAM COMPARATOR

Diagnostic Test: Transcatheter Venography

Bilateral Ovarian Vein Embolization

EXPERIMENTAL

Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Diagnostic Test: Transcatheter Venography; Procedure: Bilateral ovarian vein embolization

Interventions

Transcatheter Venography DIAGNOSTIC_TEST

Venographic assessment of ovarian veins and internal iliac veins

Also known as: Diagnostic Venography

Bilateral Ovarian Vein Embolization; Transcatheter Venography

Bilateral ovarian vein embolization PROCEDURE

Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.

Also known as: Ovarian vein and pelvic vein embolization

Bilateral Ovarian Vein Embolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 Classification18 including of one of the following:
• S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
• 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 (≥1 veins, \>5 mm diameter)
• Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Society of Interventional Radiology Foundation: collaborator
• VIVA Physicians: collaborator
• Penumbra Inc.: collaborator

Study Sites (3)

Weill Cornell Medicine

New York, New York, 10024, United States

RECRUITING

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Lake Washington Vascular

Bellevue, Washington, 98004, United States

WITHDRAWN

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald S Winokur, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald S Winokur, MD

CONTACT

646-962-9179; rsw9004@med.cornell.edu

Sasha Garcia

CONTACT

sag2958@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 13, 2023
• Study Start: August 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)