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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02717481
Enrollment
120
Registered
2016-03-23
Start date
2016-04-30
Completion date
2018-09-30
Last updated
2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal

Brief summary

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.

Detailed description

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.

Interventions

DEVICEUS-CT Fusion examination

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exact and reliable evaluation of the aneurysm sizetwo yearsThe 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.

Secondary

MeasureTime frame
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
Evaluation of the pressure on the aneurysmal wall.two years

Countries

Israel

Contacts

Primary ContactDiana Gaitini, MD, Prof.
d_gaitini@rambam.health.gov.il+972-4-7773675
Backup ContactGil Zur, MD
g_zur@rambam.health.gov.il+972-52-3504502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026