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Procedure

Bilateral Ovarian Vein Embolization for 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

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

Awards & highlights

EMBOLIZE Trial 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.Check my eligibility

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.See study design

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.

EMBOLIZE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

EMBOLIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analog Scale (VAS) for pelvic pain

Secondary outcome measures

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

Change in Patient Global Impression of Change (PGIC)

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

+1 more

EMBOLIZE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bilateral Ovarian Vein EmbolizationExperimental Treatment2 Interventions

Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Group II: Transcatheter VenographyPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for Venous and Lymphatic MedicineUNKNOWN

Penumbra Inc.Industry Sponsor

35 Previous Clinical Trials

9,070 Total Patients Enrolled

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,255 Total Patients Enrolled

1 Trials studying Pelvic Pain

55 Patients Enrolled for Pelvic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research accept volunteers over the age of 18?

"According to the clinical trial's inclusion criteria, participants should be between 18 and 75 years old."

Answered by AI

How many medical facilities are providing access to this trial?

"Currently, a quartet of medical centres are participating in this clinical trial: Lake Washington Vascular (Bellevue), Weill Cornell Medicine (New york City), University of North carolina at Chapel Hill and four other sites."

Answered by AI

Are there any spots available to participate in this experiment?

"The information hosted on clinicaltrials.gov reveals that this trial is no longer recruiting patients, as it was last modified on December 4th 2023. Despite this fact, 1531 other medical studies are currently accepting volunteers at this time."

Answered by AI

Could I potentially qualify for this medical experiment?

"Hopeful candidates for this clinical trial must be aged 18-75 and present with pelvic pain syndrome. In total, the study seeks to enrol 40 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06168058.

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