Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
464
Reference method for gestures (carried out under CT) guidance
University Hospital
Besançon, Doubs, France
University Hospital
Bordeaux, Gironde, France
Ambroise Paré University Hospital
Boulogne-Billancourt, Hauts-de-Seine, France
University Hospital
Rennes, Ille-et-Vilaine, France
Estimate the medical service of a system of navigation (IMACTIS-CT ®) in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during interventional radiology gestures
Three criteria are estimated: * Safety: number of major complications (due to gesture) * Efficiency: number of targets achieved * Performance: number of scancontrol made during the puncture
Time frame: 2 hours
Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.
Time frame: 2 hours
Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.
Scale of quantitative satisfaction
Time frame: 2 hours
Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.
Time frame: 2 hours
Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture
Time frame: 2 hours
Evaluation of the navigation system use by the operators, based on needle holder localization files
Time frame: 2 hours
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University Hospital
Tours, Indre-et-Loire, France
University Hospital
Grenoble, Isère, France
University Hospital
Nancy, Meuse, France
University Hospital
Lille, Nord, France
University Hospital of Saint-Louis
Paris, France