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

Trial Summary

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 data supports the effectiveness of the treatment Bilateral ovarian vein embolization for chronic pelvic pain?

Research shows that ovarian vein embolization is effective in treating pelvic congestion syndrome, a condition causing chronic pelvic pain. Studies indicate that this treatment has high success rates and is considered safe, although complications like coil migration can occur. ^{1 2 3 4 5}

Is vein embolization for chronic pelvic pain safe?

Vein embolization for chronic pelvic pain is generally considered safe, but there have been some reported complications, such as the migration of embolic coils used in the procedure. ^{1 2 4 5 6}

How is the treatment of bilateral ovarian vein embolization unique for chronic pelvic pain?

Bilateral ovarian vein embolization is unique because it specifically targets the veins causing pelvic congestion, a common cause of chronic pelvic pain, by blocking them with embolic coils. This non-invasive procedure is considered safer and less invasive compared to surgical options, although there is a risk of complications like coil migration. ^{1 2 4 6 7}

What is the purpose of this trial?

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.

Research Team

Ronald S Winokur, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pelvic Venous Disorders in Women due to Pelvic Varices: Treatment by Embolization: Experience in 520 Patients. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Can ovarian vein embolization cause more harm than good? [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Ovarian Vein Embolization: How and When Should It Be Done? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Techniques for Embolization of the Ovarian Vein and Pelvic Reservoir. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. [2019]

6. Israel pubmed.ncbi.nlm.nih.gov

Initial experience with ovarian vein embolization for the treatment of chronic pelvic pain syndrome. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Ovarian vein surgical ablation versus endovascular technique for treatment of pelvic vein incompetence. [2023]