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RECRUITING
NCT06590532
NA

Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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