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Validation of a Software and the Follow-up of Anteropoterior Migration of Stent

NCT05287828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2023-06-18

No results posted yet for this study

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

Conditions

  • Aortic Aneurysm

Interventions

OTHER

Surgeons CT scan analysis

Surgeons extract indicators using standard methods of analysis

DEVICE

PRAEVAorta CT scan analysis

CT scans are analysed using PRAEVAorta Suite which is composed of the software PRAEVAorta 2 and PRAEVAorta Web. Indicators extraction is fully automatic.

Sponsors & Collaborators

  • Nurea

    lead INDUSTRY

Principal Investigators

  • Lucie Dr. SALOMON DU MONT · Centre Hospitalier Universitaire Jean Minjoz Besançon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2022-09-21
Completion
2023-05-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287828 on ClinicalTrials.gov