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Could blocking pelvic veins ease chronic pain in women?

NCT ID NCT06168058

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study tests whether a procedure called ovarian and pelvic vein embolization can reduce chronic pelvic pain in women with pelvic varicose veins. Forty women with severe pain lasting over six months will be randomly assigned to either the embolization procedure or a diagnostic venography alone. The main goal is to see if the procedure improves pain and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ovarian vein and pelvic vein embolization (a procedure to block varicose veins in the pelvis)
What this could lead to
If it works, this could provide a minimally invasive treatment option for women with chronic pelvic pain caused by pelvic varicose veins.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. 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 3. 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lake Washington Vascular

    WITHDRAWN

    Bellevue, Washington, 98004, United States

  • Northwell Health Physician Partners Vascular Surgery

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • UNC School of Medicine

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10024, United States

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