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

NCT ID: NCT06180122

Last Updated: 2025-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2024-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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May-Thurner Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Symptomatic Group

Participants who are suffer from unexplained left leg swelling.

Group Type OTHER

Duplex ultrasound

Intervention Type DIAGNOSTIC_TEST

Vascular ultrasound scan of the left common iliac vein

Asymptomatic Group

Participants who do not suffer from unexplained left leg swelling

Group Type OTHER

Duplex ultrasound

Intervention Type DIAGNOSTIC_TEST

Vascular ultrasound scan of the left common iliac vein

Interventions

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Duplex ultrasound

Vascular ultrasound scan of the left common iliac vein

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Imperial College Healthcare NHS Trust

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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23CX8043

Identifier Type: -

Identifier Source: org_study_id

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