Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with known aortic aneurysm

Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it.

US-CT Fusion examination

US-CT Fusion examination

Intervention Type DEVICE

Patients will undergo an US examination using an US device with US-CT Fusion capabilities.

Interventions

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US-CT Fusion examination

Patients will undergo an US examination using an US device with US-CT Fusion capabilities.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No