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Procedure

Vein Embolization for Chronic Pelvic Pain (EMBOLIZE Trial)

N/A

Waitlist Available

Led By Ronald S Winokur, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7) as delineated by specific criteria

Pain exacerbated by walking, standing or lifting

Must not have

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

Female subject who plans to become pregnant during study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly for 4 weeks prior to day 1 and at 30, 90 and 180 day follow up

Summary

This trial 's goal is to measure the effects of embolization on women with chronic pelvic pain & varicose veins. Data will help assess quality of life changes.

Who is the study for?

This trial is for women over 18 with chronic pelvic pain linked to pelvic varicose veins, who've had the pain for more than 6 months. They should not be pregnant, planning pregnancy, or breastfeeding and must have a specific vein size on ultrasound or CT. Women post-menopause or those who've had previous vein treatments can't join.

What is being tested?

The study tests if blocking off ovarian and pelvic veins (embolization) helps reduce chronic pelvic pain in women compared to just looking at the veins (venography). It's a randomized controlled trial which means participants are randomly assigned to one of these two approaches.

What are the potential side effects?

Possible side effects from embolization may include discomfort at the injection site, allergic reactions to materials used like coils or catheters, and complications related to endovascular procedures such as bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had severe pelvic pain for more than 6 months.

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My pain gets worse when I walk, stand, or lift things.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a major narrowing in my iliac vein.

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I plan to become pregnant during the study.

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I am currently breastfeeding.

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I am post-menopausal or do not ovulate.

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My kidney veins are narrowed, causing vein enlargement and backflow as seen in a vein scan.

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I am a female under 18 years old.

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I have had a procedure to block or tie off my ovarian veins.

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I cannot undergo certain medical procedures due to my current health condition.

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I will be receiving nerve block treatments during the study.

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I will have or am planning to have surgery during the study.

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I have severe kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly for 4 weeks prior to day 1. then at 30, 90 and 180 day follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly for 4 weeks prior to day 1. then at 30, 90 and 180 day follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 4 weeks prior to day 1. then at 30, 90 and 180 day follow up for reporting.