At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Retrospective Study for the Validation of an Automatic Software for Geometric Measurements of the Principal Arteries and Calcification Detection on Patients With Aortic Aneurysm.
In Brief
An observational study evaluating Surgeons CT scan analysis and PRAEVAorta CT scan analysis for Aortic Aneurysm. Completed, enrolled 65 participants across 1 site.
Detailed Summary
The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure. They demand training and practice. Nurea is developing a software for automatic measurement of these indicators, PRAEVAorta® 2, to facilitate and assist the physician in his clinical routine. The purpose of this study is to compare the analysis realised by the software PRAEVAorta® 2 with the analysis realised by the healthcare professional on retrospective CT scan images. Contrasted and non-contrasted, pre-operation or post-operation CT scans from 50 patients will be analysed. The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis. The second objectives are the following: * Evaluate the security of the software PRAEVAorta® 2 * Evaluate the unanticipated risks related to the use of the software * Validate the accessory PRAEVAorta® Web We make the following assumption : 90% of the patients show 90% of adequacy to the healthcare professional analysis
Study Details
Timeline
Interventions
Surgeons extract indicators using standard methods of analysis
CT scans are analysed using PRAEVAorta Suite which is composed of the software PRAEVAorta 2 and PRAEVAorta Web. Indicators extraction is fully automatic.