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Clinical Trials/NCT06180122
NCT06180122
Completed
Not Applicable

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

Imperial College London1 site in 1 country40 target enrollmentMarch 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
May-Thurner Syndrome
Sponsor
Imperial College London
Enrollment
40
Locations
1
Primary Endpoint
Left Common Iliac Vein Diameter
Status
Completed
Last Updated
8 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 5, 2024
End Date
May 21, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein(Baseline)

Study Sites (1)

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