WithdrawnNot Applicable

Comparative Study of a Software With the Gold Standard

Stopped: The study had to be cancelled do to the Covid-19 pandemic

France0Started 2020-03-01

Plain-language 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%.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female * Patient equal or over 18 years old * Patient who has given and signed is informed consent * Patient with a diagnosed aneurysm * Infra-renal AAA * ≥50mm * or ≥5mm increase in 6 months * or Ruptured AAA * Patient with legal capacity to make its own decisions, * Patient available for set-up and proper implementation of follow-up visits throughout the duration of the registry Exclusion Criteria: * Pregnant or planning on becoming pregnant * Advancing Alzheimer's disease or socially dependent patient * Patient on opposition to the use of their data for this research * Patient under the age of 18 * Incapable adult * Patient under guardianship, curatorship, or safeguard of justice

What they're measuring

AAA maximum diameter

Timeframe: First week

AAA volume

Timeframe: First week

Trial details

NCT IDNCT04551183

SponsorNurea

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09