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Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Sponsor: Nantes University Hospital
Summary
Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a French multicentre clinical setting. The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). This will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available
Official title: French Randomised Controlled Trial Investigating the Clinical and Cost-effectiveness Role of a Cloud-based, Artificial Intelligent Image Fusion System to Guide Endovascular Aortic Aneurysm Repair and Aorto Iliac Revascularisation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-12-10
Completion Date
2026-05-01
Last Updated
2024-12-19
Healthy Volunteers
No
Conditions
Interventions
Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.
Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)
Locations (7)
Rinckenbach
Besançon, Besançon, France
NASR
Brest, Brest, France
El Batti
Créteil, Créteil, France
Spear
Grenoble, Grenoble, France
Pr Blandine Maurel
Nantes, Nantes, France
Jean-Baptiste
Nice, Nice, France
Duprey
Reims, Reims, France