NCT06590532

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard X-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system. The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included. Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.

Conditions

• Endovascular

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2024-09-19
• Last updated: 2024-12-19

Locations

7 sites across 1 country: France