Vein Embolization for Chronic Pelvic Pain

(EMBOLIZE Trial)

Recruiting at 4 trial locations

Overseen By Kush Desai, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnancy, Breastfeeding, Post-menopausal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ovarian vein embolization, a minimally invasive treatment, can enhance the quality of life for women with chronic pelvic pain and varicose veins in the pelvic area. Participants will either undergo the embolization treatment or a procedure that examines veins without treatment. Women experiencing pelvic pain that worsens with activities like walking or standing, and who find relief when lying down, may be suitable candidates for this study. As an unphased trial, this study provides participants the chance to contribute to important research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that bilateral ovarian vein embolization is safe for women with chronic pelvic pain?

Research has shown that ovarian vein embolization is generally safe and effective for treating chronic pelvic pain caused by vein problems in the pelvis. Studies have found the procedure to be successful 94% of the time. Complications occur in 9% of cases, with most being minor. Only about 10% of these complications are more serious, yet they remain uncommon. This treatment has been well-studied and is usually well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about bilateral ovarian vein embolization for chronic pelvic pain because it offers a minimally invasive alternative to current treatments like medication or surgery. Unlike these standard treatments, which can involve significant downtime and side effects, embolization targets the source of pain directly by blocking problematic veins, potentially providing quicker relief. This method could significantly reduce recovery time and improve quality of life, making it a promising option for those suffering from this challenging condition.

What evidence suggests that bilateral ovarian vein embolization might be an effective treatment for chronic pelvic pain?

This trial will compare Bilateral Ovarian Vein Embolization with a sham procedure. Research has shown that blocking blood flow in the ovarian veins can reduce chronic pelvic pain. Studies have found a noticeable decrease in pain levels after this procedure, often measured using a simple pain rating scale. One study confirmed that this treatment was both safe and effective for pain related to pelvic vein issues. Another review found that patients continued to experience less pain long after the procedure. Overall, this treatment offers promising results for those suffering from chronic pelvic pain due to problems with pelvic veins. ^{2 3 6 7 8}

Who Is on the Research Team?

Ronald S Winokur, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Left or right ovarian vein diameter greater than or equal to 6 mm

I experience long-lasting pain after sex.

Absence of non-venous origin CPP as determined by Gynecology examination

Exclusion Criteria

Known allergy to sclerosant, coil, stent or catheter components including nickel allergy

I have a major narrowing in my iliac vein.

I plan to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Weekly visits

Treatment

Participants undergo either bilateral ovarian vein embolization or venography alone

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in quality of life and pain intensity

6 months

Weekly for 4 weeks, then at 1, 3, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral ovarian vein embolization

Trial Overview

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.

How Is the Trial Designed?

Group I: Bilateral Ovarian Vein Embolization Experimental Treatment 2 Interventions

Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Group II: Transcatheter Venography Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Penumbra Inc.

Industry Sponsor

Trials

38

Recruited

10,800+

Foundation for Venous and Lymphatic Medicine

Collaborator

Trials

1

Recruited

40+

Society of Interventional Radiology Foundation

Collaborator

Trials

6

Recruited

2,300+

VIVA Physicians

Collaborator

Trials

5

Recruited

310+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9536205/

Efficacy of the endovascular ovarian vein embolization ...

The aim of this study was to determine factors affecting the success of endovascular venous embolization used in the treatment of PVCS, and to present the long- ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213333X2200436X

Review articles Pelvic venous reflux embolization in the ...

All included studies reported a significant decrease in chronic pelvic pain after PVE, from the mean score measured by VAS, with significant maintenance of ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06168058?term=AREA%5BConditionSearch%5D(Pelvic)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-07-23,MAX%5D&rank=7

Trial of Ovarian Vein and Pelvic Vein Embolization in ...

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) ...

4.

jvsvenous.org

jvsvenous.org/article/S2213-333X(25)00091-5/fulltext

Efficacy and safety of ovarian vein embolization with N- ...

In our study, ovarian vein embolization with NBCA appears to be a safe and effective treatment for pelvic venous disorder-associated chronic pelvic pain, ...

5.

uhcprovider.com

uhcprovider.com/content/dam/provider/docs/public/policies/umr/embolization-ovarian-iliac-veins-pelvic-congestion-syndrome-umr.pdf

embolization-ovarian-iliac-veins-pelvic-congestion- ...

The relationship between pelvic vein incompetence and chronic pelvic pain in women: systematic reviews of diagnosis and treatment effectiveness.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213333X25000915

Efficacy and safety of ovarian vein embolization with N- ...

In our study, ovarian vein embolization with NBCA appears to be a safe and effective treatment for pelvic venous disorder-associated chronic pelvic pain, ...

7.

link.springer.com

link.springer.com/article/10.1007/s11845-024-03608-6

Efficacy of embolotherapy for the treatment of pelvic ...

Transcatheter embolisation had a high technical success rate (94%) and an overall complication rate of 9.0%, of which 10.4% were major and 89.6% ...

8.

trialx.com

trialx.com/clinical-trials/listings/312371/trial-of-ovarian-vein-and-pelvic-vein-embolization-in-women-with-chronic-pelvic-pain-and-pelvic-varices/

Trial of Ovarian Vein and Pelvic Vein Embolization in ...

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) ...