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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06168058
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain Syndrome
  • Pelvic Congestive Syndrome
  • Pelvic Pain
  • Pelvic Pain Syndrome
  • Pelvic Varices

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Transcatheter Venography — DIAGNOSTIC_TEST
    Venographic assessment of ovarian veins and internal iliac veins
  • Bilateral ovarian vein embolization — PROCEDURE
    Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Transcatheter Venography
  • Experimental: Bilateral Ovarian Vein Embolization
    Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10024
Ronald S Winokur, MD (PRINCIPAL_INVESTIGATOR)
UNC School of MedicineChapel HillNorth Carolina27599
Gloria Salazar, MD (PRINCIPAL_INVESTIGATOR)
Lake Washington VascularBellevueWashington98004-

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Weill Cornell Medicine· New York, NYUNC School of Medicine· Chapel Hill, NCLake Washington Vascular· Bellevue, WA

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