The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Dia… (NCT06180122) | Clinical Trial Compass
CompletedNot Applicable
The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter
United Kingdom40 participantsStarted 2024-03-05
Plain-language summary
The goal of this feasibility/pilot study is to investigate whether or not vascular ultrasound can be used to aid the diagnosis of May Thurner Syndrome, in adult patients presenting to the vascular department with unexplained left leg swelling. The main research objective it aims to answer are:
* The diameter variation of the left common iliac vein based on posture, using duplex ultrasound.
* To determine inter- and intra-observer variation of the diameter measurement of the left common iliac vein using duplex ultrasound.
Participants will have an ultrasound scan performed on their abdomen by three different clinical vascular scientists, and will have each scan performed whilst lying supine on an examination couch and again when the couch is tilted to 45 degrees.
Researchers will compare the results of symptomatic patients to asymptomatic patients, to see if there is a difference in the diameter of the left common iliac vein between these two groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant has the capacity to consent
* Participant is required to have a vascular ultrasound scan in the vascular ultrasound department
* Participant is 18 years of age or older at the start of the study.
Exclusion Criteria:
* Previous iliac vein intervention or treatment for iliac vein disease
* Previous diagnosis of iliac vein thrombus
* Pregnancy
* Unable to provide appropriate informed consent
* The participant does not require a vascular ultrasound as part of their routine care
* Under 18 years of age at the start of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used duplex ultrasound to measure the left common iliac vein diameter — is that the same type of imaging you would use to evaluate me for May-Thurner Syndrome, and how reliable is it compared to other options like CT or MRI?
2Since this trial was focused on measuring reproducibility of the ultrasound technique rather than testing a treatment, does the research tell us anything useful about how consistently my vein compression could be detected or monitored over time?
3The study specifically measured the left common iliac vein diameter as its main outcome — what diameter measurement would actually be considered significant or concerning in my case, and how does that guide treatment decisions?
4Given that this was a completed observational study rather than a treatment trial, what are the current standard treatment options for May-Thurner Syndrome that I should be considering alongside any diagnostic findings?
5Would the findings from a study like this change how you approach my diagnosis, or is duplex ultrasound already part of your standard workup for suspected May-Thurner Syndrome?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.