NCT06168058

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-07
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-12-13
• Last updated: 2026-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study