Ablation, Biopsy, Drainage, Punction
Conditions
Keywords
Medical device, CT, Needle, Navigation, IMACTIS-CT®, Thoraco-abdominal level, anesthesia needles
Brief summary
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.
Interventions
DEVICENavigation station (IMACTIS-CT®)
DEVICECT
Reference method for gestures (carried out under CT) guidance
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 hours | Scale of quantitative satisfaction |
| 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 | — |
Countries
France
Outcome results
None listed