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

RecruitingNAAges 18 Years - anyAllNantes University Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available * Surgeon trained in the use of image fusion * Operator who has given their consent * Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft * Patient in possession of an angioscan less than 6 months old * Patient of legal age who has given his/her consent * Ionising radiation generator with up-to-date and validated quality control * Participant affiliated to a Social Security scheme Exclusion Criteria: * First procedure with fusion for the previously trained surgeon. * Procedure performed without an operating aid. * Emergency procedure. * Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch). digestive arteries, iliac branch). * Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft) * Aortic emergencies (ruptured AAA). * Persons under guardianship, curatorship or safeguard of justice * Pregnant or breast-feeding women.
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What it tests

  • Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
  • Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
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Where

7 sites
Rinckenbach
Besançon, France
NASR
Brest, France
El Batti
Créteil, France
Spear
Grenoble, France
Pr Blandine Maurel
Nantes, France
Jean-Baptiste
Nice, France
Duprey
Reims, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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