Actively Recruiting
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Led by Nantes University Hospital · Updated on 2024-12-19
350
Participants Needed
7
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
- Patients with AAA that cannot be treated by a simple sub-renal endovascular approach (subrenal bifurcated stent graft)
- Aortic emergencies (ruptured AAA)
- Persons under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Rinckenbach
Besançon, Besançon, France, 25000
Not Yet Recruiting
2
NASR
Brest, Brest, France, 29200
Not Yet Recruiting
3
El Batti
Créteil, Créteil, France, 94000
Not Yet Recruiting
4
Spear
Grenoble, Grenoble, France, 38000
Not Yet Recruiting
5
Pr Blandine Maurel
Nantes, Nantes, France, 44000
Actively Recruiting
6
Jean-Baptiste
Nice, Nice, France, 06000
Not Yet Recruiting
7
Duprey
Reims, Reims, France, 51100
Not Yet Recruiting
Research Team
B
Blandine Maurel, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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