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

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ClinicalTrials.gov Identifier: NCT02717481
Recruitment Status : Unknown
Verified March 2016 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: US-CT Fusion examination

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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




Primary Outcome Measures :
  1. Exact and reliable evaluation of the aneurysm size [ Time Frame: 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.



Secondary Outcome Measures :
  1. The size difference between systolic and diastolic aneurysm. [ Time Frame: two years ]
  2. Aneurysm neck size and changes following an invasive procedure to repair it (EVAR). [ Time Frame: two years ]
  3. Evaluation of the pressure on the aneurysmal wall. [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717481


Contacts
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Contact: Diana Gaitini, MD, Prof. +972-4-7773675 d_gaitini@rambam.health.gov.il
Contact: Gil Zur, MD +972-52-3504502 g_zur@rambam.health.gov.il

Locations
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Israel
Rambam healt care campus, Department of Medical Imaging
Haifa, Israel, 3109601
Contact: Diana Gaitini, MD, Prof.    +972 (4)777-2664    d_gaitini@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Diana Gaitini, MD, Prof. Director of Ultrasound Unit, Rambam Health Care Campus
Publications:
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02717481    
Other Study ID Numbers: 0551-15 RMB CTIL
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases