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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00539-36 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gesture performed under control tomodensitometric (CT) | Active Comparator | Conventional |
|
| Gesture performed under Navigation-assisted procedure (NAV) | Experimental | Use of the IMACTIS-CT® Navigation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation station (IMACTIS-CT®) | Device |
|
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| 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:
| 2 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Bricault, Pr | Radiology Departement - University Hospital of Grenoble | Principal Investigator |
| Eric Delabrousse, Pr | University Hospital of Besançon | Principal Investigator |
| Bruno Lapuyade, MD | University Hospital, Bordeaux | Principal Investigator |
| Pascal Lacombe, Pr | University Hospital of Garches | Principal Investigator |
| Laurent Lemaitre, Pr | University Hospital of Lille | Principal Investigator |
| Valérie Laurent, Pr | Central Hospital, Nancy, France | Principal Investigator |
| Jean-Yves Gauvrit, Pr | University Hospital of Rennes | Principal Investigator |
| Olivier Favelle, MD | University Hospital of Tours | Principal Investigator |
| Eric De Kerviler, Pr | University Hospital of Saint-Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Besançon | Doubs | 25030 | France | ||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683837 | Derived | Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6. |
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| CT | Device | Reference method for gestures (carried out under CT) guidance |
|
| 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 |
| Bordeaux |
| Gironde |
| 33604 |
| France |
| Ambroise Paré University Hospital | Boulogne-Billancourt | Hauts-de-Seine | 92100 | France |
| University Hospital | Rennes | Ille-et-Vilaine | 35033 | France |
| University Hospital | Tours | Indre-et-Loire | 37044 | France |
| University Hospital | Grenoble | Isère | 38043 | France |
| University Hospital | Nancy | Meuse | 54511 | France |
| University Hospital | Lille | Nord | 59037 | France |
| University Hospital of Saint-Louis | Paris | 75475 | France |