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临床试验/NCT06180122
NCT06180122已完成不适用

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 London2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Left Common Iliac Vein Diameter

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Left Common Iliac Vein Diameter

时间窗: Baseline

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

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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