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Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis

NCT05920317 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-06-27

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

  • Abdominal Aortic Aneurysm

Sponsors & Collaborators

  • Universitätsklinikum Leipzig

    collaborator OTHER

  • Nurea

    lead INDUSTRY

Principal Investigators

  • Daniela Dr. Med. BRANZAN · UNIVERSITY CLINIC LEIPZIG AöR

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2023-11-28
Completion
2023-12-28

Countries

  • Germany

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 NCT05920317 on ClinicalTrials.gov