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

NCT06180122 | Completed Results

• 1 other identifier: 23CX8043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

May-Thurner Syndrome

Outcome Measures

Primary Outcomes (1)

• Left Common Iliac Vein Diameter

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

  Baseline

Secondary Outcomes (1)

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

  Baseline

Study Arms (2)

Symptomatic Group

OTHER

Participants who are suffer from unexplained left leg swelling.

Diagnostic Test: Duplex ultrasound

Asymptomatic Group

OTHER

Participants who do not suffer from unexplained left leg swelling

Diagnostic Test: Duplex ultrasound

Interventions

Duplex ultrasound DIAGNOSTIC_TEST

Vascular ultrasound scan of the left common iliac vein

Asymptomatic Group; Symptomatic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, Greater London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

May-Thurner Syndrome

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Limitation due to non-visualization of the CIV in some participants - In one participant no readings/data could be obtained, and in three participants only partial data could be obtained.

Results Point of Contact

• Title: Sophie Connolly
• Organization: Imperial College Healthcare NHS Trust

sophie.connolly1@nhs.net

02033117322

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: March 5, 2024
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: September 3, 2025
• Results First Posted: September 3, 2025

Record last verified: 2025-08

Locations

GB (1)