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Comparative Study of a Software With the Gold Standard

NCT04551183 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-18

No results posted yet for this study

Summary

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%.

Conditions

  • Abdominal Aortic Aneurysm (AAA)

Interventions

OTHER

Surgeons CT scan analysis

Surgeons extract diameter by hand (Gold Standard method) then realised a semi-manual segmentation of the images to extract volumes and diameters of the aorta (espacially AAA)

DEVICE

PRAEVAorta CT scan analysis

CT scans are analysed by the software under investigation : PRAEVAorta. It will extract volumes and diameters of the aorta (AAA espacially)

Sponsors & Collaborators

  • Nurea

    lead INDUSTRY

Principal Investigators

  • Eric DUCASSE · Universitary Hospital Pellegrin

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-09-30
Completion
2022-09-30

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 NCT04551183 on ClinicalTrials.gov