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Hidden pelvic vein issues may sabotage leg vein surgery, study warns

NCT ID NCT07680465

Knowledge-focused Sponsor: Chengdu University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks at how often pelvic congestion syndrome (a condition where veins in the pelvis become enlarged and painful) occurs in women who are about to have a standard procedure for leg varicose veins. Researchers want to know if having this pelvic condition affects how much women's quality of life improves after leg vein treatment. About 300 women aged 20 to 60 with leg varicose veins will get a pelvic MRI and answer symptom questions before and after their leg vein procedure. The goal is to see whether undiagnosed pelvic vein problems are a hidden reason why some women don't feel better after leg vein treatment.

What this could mean

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

Active substance
radiofrequency ablation (device)
What this could lead to
If pelvic congestion syndrome is found to be a common hidden cause of leg varicose veins, future care could screen for it before leg vein treatment, leading to better outcomes.
What could go wrong
This is an observational study, not a treatment trial. It will not test whether treating pelvic veins improves results, so any changes in practice remain speculative.

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.

Participants

About 300 people

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

Started

May 2026

Expected to finish

Sep 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.

Who is studied

Chronic pelvic pain is a common issue among women of reproductive age, with Pelvic Congestion Syndrome (PCS) being a significant etiological factor, second only to pelvic adhesions and endometriosis . The fundamental pathology of PCS is pelvic-genital-perineal venous insufficiency. The resulting venous hypertension not only causes chronic pelvic pain but can also become an important upstream cause for the development or exacerbation of lower limb varicose veins in women via the extensive pelvic-lower limb venous collaterals . However, systematic screening for PCS is generally lacking in current clinical practice for female patients scheduled for lower limb venous surgery. The 2025 French multi-society consensus clearly states that the diagnosis of PCS must be based on the triad of clinical symptoms, physical examination, and imaging evidence, while excluding other gynecological diseases, opposing diagnosis based solely on imaging findings of venous dilation. This leads to a s

Ages

20 to 60 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. Female, aged 20-60 years. 2. Symptomatic lower limb varicose veins, CEAP clinical class C2-C6, planned for ultrasound-guided radiofrequency ablation. 3. Voluntary participation with signed informed consent. Exclusion Criteria: 1. History of deep vein thrombosis or previous lower limb venous surgery. 2. Pregnancy, lactation, or planning pregnancy within 1 year. 3. Severe systemic disease or active malignancy. 4. Other established causes of chronic pelvic pain (Critical Modification).

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Conditions

The condition(s) this trial relates to.

pelvic congestion syndrome varicose disease

As listed by the trial registrant

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

Lower limb varicose veins Pelvic venous congestion syndrome Radiofrequency ablation

Contacts and locations

Locations

  • Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuang, 610072, China

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