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

Recruiting now · Not applicable

Conditions studied: Endovascular

In brief

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

Key facts

Study ID

NCT06590532

Run by

Nantes University Hospital

People needed

350

Starts

2024-12-10

Expected to finish

2026-05-01

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pr Blandine Maurel — Nantes, Nantes, France (enrolling)
• NASR — Brest, Brest, France
• El Batti — Créteil, Créteil, France
• Rinckenbach — Besançon, Besançon, France
• Jean-Baptiste — Nice, Nice, France
• Duprey — Reims, Reims, France
• Spear — Grenoble, Grenoble, France

Full record on ClinicalTrials.gov

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