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Completed

NCT Number: NCT06180122

The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein Diameter

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.

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Key information

Conditions

May-Thurner Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Peripheral Vascular Diseases Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College Healthcare NHS Trust

London, Greater London, W6 8RF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duplex ultrasound

Diagnostic Test

Vascular ultrasound scan of the left common iliac vein

Primary outcomes

  1. Left Common Iliac Vein Diameter

    Time frame: Baseline

    The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.

Secondary outcomes

  1. Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein

    Time frame: Baseline

    The inter- and intra-operator variation of the diameter measurement of the left common iliac vein using duplex ultrasound, in adults referred to the vascular ultrasound department. Three different scientists took three measurements each of the common iliac vein. The results from the three scientists were compared to determine inter-operator variation, and the results from one scientist each were compared to determine intra-operator variation.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

The Use and Reproducibility of Duplex Ultrasound to Provide Indices of Left Common Iliac Vein (CIV) Diameter, to Aid and Improve the Diagnosis of May Thurner Syndrome (MTS) in Patients Presenting With Unexplained Left Leg Swelling

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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