Comparative Study of a Software With the Gold Standard

NCT04551183 | Withdrawn

• 1 other identifier: 2020-A02270-39
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Automatic segmentation; Abdominal Aortic Aneurysm (AAA); Artificial Intelligence (AI); Deep learning; Automatic volume segmentation; CT scan

Outcome Measures

Primary Outcomes (2)

• AAA maximum diameter

  Measured in millimeter (mm)

  First week

• AAA volume

  Measured in cubic millimeter (mm3)

  First week

Study Arms (1)

OnlyGroup

EXPERIMENTAL

Patients are their own witnesses

Other: Surgeons CT scan analysis; Device: PRAEVAorta CT scan analysis

Interventions

Surgeons CT scan analysis OTHER

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)

OnlyGroup

PRAEVAorta CT scan analysis DEVICE

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

OnlyGroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurea: lead

Study Sites (1)

Hopital Universitaire Pellegrin Bordeaux

Bordeaux, 33000, France

Location

Related Publications (3)

• Schnitzbauer M, Guntner O, Wohlgemuth WA, Zeman F, Haimerl M, Stroszczynski C, Muller-Wille R. CT after Endovascular Repair of Abdominal Aortic Aneurysms: Diagnostic Accuracy of Diameter Measurements for the Detection of Aneurysm Sac Enlargement. J Vasc Interv Radiol. 2018 Feb;29(2):178-187.e3. doi: 10.1016/j.jvir.2017.09.012. Epub 2017 Dec 6.

  PMID: 29217411 BACKGROUND

• Kauffmann C, Tang A, Therasse E, Giroux MF, Elkouri S, Melanson P, Melanson B, Oliva VL, Soulez G. Measurements and detection of abdominal aortic aneurysm growth: Accuracy and reproducibility of a segmentation software. Eur J Radiol. 2012 Aug;81(8):1688-94. doi: 10.1016/j.ejrad.2011.04.044. Epub 2011 May 20.

  PMID: 21601403 BACKGROUND

• Lareyre F, Adam C, Carrier M, Dommerc C, Mialhe C, Raffort J. A fully automated pipeline for mining abdominal aortic aneurysm using image segmentation. Sci Rep. 2019 Sep 24;9(1):13750. doi: 10.1038/s41598-019-50251-8.

  PMID: 31551507 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Eric DUCASSE

  Universitary Hospital Pellegrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is comparative, retrospective, monocentric, open, controlled. We compare the SaMD to the Gold Standard. The data used are CT scans which have already been analysed by the doctors. The study will be realised on a group of 40 subjects which is small enough to have one site of investigation. Subjects will be their own witness. This investigation is NRIPH regarding the "Loi Jardé" since it is on retrospective data. Pivotal stage: pivotal, confirmatory, and interventional clinical investigation. This premarket study aims is to confirm the clinical performance, efficiency, and the security of the medical device PRAEVAorta. To do so, a hypothesis has been defined (cf. VI.2.) and the number of patients has been strictly defined and justified (VII.3). CT scan images of patients are analyzed by the surgeons and then by the software under investigation. The results are then compared.

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 16, 2020
• Study Start: March 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 18, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)