CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Study Overview
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Brief Summary
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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.

Official Title
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Multicentric Evaluation of IMACTIS-CT Navigation System

Conditions
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Drainage, Biopsy, Punction, Ablation

Intervention / Treatment
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* Device: Navigation station (IMACTIS-CT®)
* Device: CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More or equal the 18 years old Patient for whom an indication of diagnostic or therapeutic percutaneous interventional gesture in the thoraco-abdominal level under CT guidance is prescribed Patient affiliated to social security or similarly regime Patient signed consent for participation in the study. Exclusion Criteria: Patient with a medical device using a magnetic field (eg, patient with a pacemaker) Patient who presents ferromagnetic foreign bodies intracorporeal close to the working zone of Radiologist, and that can interact with the medical device Pregnant women and lactating mothers Ward of court or under guardianship Person deprived of freedom by judicial or administrative decision Person under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gesture performed under control tomodensitometric (CT)<br>Conventional | Device: CT<br>* Reference method for gestures (carried out under CT) guidance<br>|
| Experimental: Gesture performed under Navigation-assisted procedure (NAV)<br>Use of the IMACTIS-CT® Navigation System | Device: Navigation station (IMACTIS-CT®)<br> <br> * Other names: Navigation station for gestures (carried out under CT) guidance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method. |  | 2 hours | 
| Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture. | Scale of quantitative satisfaction | 2 hours | 
| Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture. |  | 2 hours | 
| Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture |  | 2 hours | 
| Evaluation of the navigation system use by the operators, based on needle holder localization files |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, Medical device, Needle, Navigation, IMACTIS-CT®, Thoraco-abdominal level, anesthesia needles