Chronic Pelvic Pain SyndromeEMBOLIZENCT06168058
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
A study testing Transcatheter Venography and Bilateral ovarian vein embolization in people with Chronic Pelvic Pain Syndrome and Pelvic Pain, run by Weill Medical College of Cornell University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Pain Syndrome, Pelvic Pain, Pelvic Varices
- What is being tested?
- Transcatheter Venography and Bilateral ovarian vein embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
- Pain exacerbated by walking, standing or lifting
- Symptoms are at least partially alleviated by lying down
- Prolonged post-coital ache
- Absence of non-venous origin CPP as determined by Gynecology examination
- Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
Show all 11Show fewer
- •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
- CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
- Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
- Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, >5 mm diameter)
- Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
Who cannot join
- Female <18 years of age
- Pregnancy (positive pregnancy test)
- Female subject who plans to become pregnant during study period
- Female subject who is actively breastfeeding
- Patient who is post-menopausal or anovulatory with hormone suppression
- History of prior hysterectomy
Show all 20Show fewer
- Prior ovarian vein embolization or ovarian vein ligation
- Inability to tolerate endovascular procedure due to acute illness or general health
- Planned simultaneous treatment with nerve blocks during the duration of the study
- Laparoscopy or planned surgical intervention during the duration of the study
- Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
- Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
- Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
- Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
- Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
- Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
- Severe renal impairment (on chronic dialysis or estimated GFR <30 mL/min)
- Hemoglobin <8.0 g/dL, uncorrectable INR >3.0 or platelet count <75,000/microliter
- Inability to provide informed consent or to comply with study assessments
- Post thrombotic IVC, iliac or ovarian vein changes
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sasha Garcia contact
5 sites in 1 country
United States5 sites, 4 recruiting
- Withdrawn
Lake Washington Vascular
Bellevue, Washington, 98004
- Recruiting
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Gloria Salazar, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Adam Alli, MD
- Recruiting
Northwell Health Physician Partners Vascular Surgery
New Hyde Park, New York, 11042
- Recruiting
Weill Cornell Medicine
New York, New York, 10024
Neil K Khilnani, MD
About this study
Official title: 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
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.
Read the 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
- Being tested
- Transcatheter Venography, Bilateral ovarian vein embolization
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter VenographyDiagnostic test
Also called Diagnostic Venography
Venographic assessment of ovarian veins and internal iliac veins
Bilateral ovarian vein embolizationProcedure or surgery
Also called Ovarian vein and pelvic vein embolization
Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Venography | Sham comparator | Not described Receives: Diagnostic Test: Transcatheter Venography |
| Bilateral Ovarian Vein Embolization | Experimental | Transcatheter Venography plus Bilateral Ovarian Vein Embolization. Receives: Diagnostic Test: Transcatheter Venography; Procedure: Bilateral ovarian vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) for pelvic pain
The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''
Measured: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Secondary outcomes (4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale
The Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale assess how much a person hurts. The scale ranges from 1-5, defining 1 as ''no pain'' and 5 ''very severe pain.''
Measured: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measures assess an individual's physical, mental, and social health. The scale scores from from 5 to 1 with 5 = "Excellent" and 1= "Poor ".
Measured: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient Global Impression of Change (PGIC)
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale with 1= "Very Much Improved" and 7= "Very Much Worse".
Measured: 30, 90 and 180 day follow up
Change in EuroQol five-dimension (EQ-5D) scale
The EuroQol five-dimension (EQ-5D) is a concise, generic measure of self-reported health at each visit. Patients will tick the one box that best describes their health on that day. This scale will measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The scale is numbered from 0 to 100. =100 means the best health the patient can imagine and 0 means the worst health the patient can imagine,.
Measured: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start29 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Interventional Radiology Foundation, VIVA Physicians, Penumbra Inc.
- Responsible party
- Sponsor
- Investigators
- Neil M Khilnani, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168058
- Sponsor's protocol ID
- 23-08026405
- Acronym
- EMBOLIZE
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06168058
- Acronym / sponsor ID
- EMBOLIZE / 23-08026405
- Conditions
- Chronic Pelvic Pain Syndrome, Pelvic Pain, Pelvic Varices, Pelvic Congestive Syndrome, Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Society of Interventional Radiology Foundation, VIVA Physicians, Penumbra Inc.
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Venography | Sham comparator | Diagnostic Test: Transcatheter Venography |
| Bilateral Ovarian Vein Embolization | Experimental | Diagnostic Test: Transcatheter Venography, Procedure: Bilateral ovarian vein embolizationTranscatheter Venography plus Bilateral Ovarian Vein Embolization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
- Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
- •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
- CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
Key exclusion criteria (20 listed)
- Female <18 years of age
- Pregnancy (positive pregnancy test)
- Female subject who plans to become pregnant during study period
- Female subject who is actively breastfeeding
- Patient who is post-menopausal or anovulatory with hormone suppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter VenographyAlso: Diagnostic VenographyVenographic assessment of ovarian veins and internal iliac veins | Diagnostic test | Bilateral Ovarian Vein Embolization, Transcatheter Venography |
| Bilateral ovarian vein embolizationAlso: Ovarian vein and pelvic vein embolizationIntervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins. | Procedure or surgery | Bilateral Ovarian Vein Embolization |
Primary outcome
Change in Visual Analog Scale (VAS) for pelvic pain
Time frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''
4 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale
Time frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale
Time frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient Global Impression of Change (PGIC)
Time frame: 30, 90 and 180 day follow up
Change in EuroQol five-dimension (EQ-5D) scale
Time frame: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Garcia contact
Neil M Khilnani, MD principal investigator
Weill Medical College of Cornell University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Venography and Bilateral ovarian vein embolization in people with Chronic Pelvic Pain Syndrome and Pelvic Pain, run by Weill Medical College of Cornell University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil M Khilnani, MD (646-962-9179, EMBOLIZE@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) for pelvic pain (time frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.