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

R

Rambam Health Care Campus

Status

Unknown

Conditions

Aortic Aneurysm, Abdominal

Treatments

Device: US-CT Fusion examination

Study type

Observational

Funder types

Other

Identifiers

NCT02717481
0551-15 RMB CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Patients with known aortic aneurysm
Description:
Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination
Treatment:
Device: US-CT Fusion examination

Trial contacts and locations

1

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Central trial contact

Diana Gaitini, MD, Prof.; Gil Zur, MD

Data sourced from clinicaltrials.gov

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