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Abdominal Aortic Aneurysm (AAA) clinical trials

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NCT ID: NCT04551183 Withdrawn - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Comparative Study of a Software With the Gold Standard

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study. Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm. The currently benchmark methods are the maximal diameter method (Hand-held measurement of maximum diameter on scan images) and the segmentation method for the aneurysm volume (manual segmentation of scan images, then calculation of the AAA volume by counting the pixels). The hypothesis is that 90% of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90%.