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临床试验/NCT02717481
NCT02717481Unknown不适用

Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Exact and reliable evaluation of the aneurysm size

研究概览

简要总结

Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

详细描述

Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture.

Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a "roadmap" for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.

排除标准

  • Inability to perform Ultrasound
  • Pace maker
  • Hemodynamic instability
  • Inability to cooperate in US examination
  • Pregnant Women - does not undergo CT

结局指标

主要结局

Exact and reliable evaluation of the aneurysm size

时间窗: two years

The size of the aneurysm will be evaluated by two different doctors or twice with large time frame between the studies. The difference between the measurements with the fusion technology will be compared to the difference without the fusion technology. The accuracy of the measurement will be evaluated by comparing to previous CT examination.

次要结局

  • Evaluation of the pressure on the aneurysmal wall.(two years)
  • The size difference between systolic and diastolic aneurysm.(two years)
  • Aneurysm neck size and changes following an invasive procedure to repair it (EVAR).(two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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