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

NCT06168058 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Transcatheter Venography

Venographic assessment of ovarian veins and internal iliac veins

PROCEDURE

Bilateral ovarian vein embolization

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

Sponsors & Collaborators

  • Society of Interventional Radiology Foundation

    collaborator OTHER

  • VIVA Physicians

    collaborator OTHER

  • Penumbra Inc.

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Ronald S Winokur, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168058 on ClinicalTrials.gov