Clinical trial NCT01896219: CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System
Official title: Multicentric Evaluation of IMACTIS-CT Navigation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drainage
Biopsy
Punction
Ablation
Keywords: Medical device
CT
Needle
Navigation
IMACTIS-CT®
Thoraco-abdominal level
anesthesia needles
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 hours
Secondary outcomes:
measure: Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.
timeFrame: 2 hours
measure: Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.
timeFrame: 2 hours
measure: Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.
timeFrame: 2 hours
measure: Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture
timeFrame: 2 hours
measure: Evaluation of the navigation system use by the operators, based on needle holder localization files
timeFrame: 2 hours
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
state: Doubs
city: Bordeaux
country: France
facility: University Hospital
state: Gironde
city: Boulogne Billancourt
country: France
facility: Ambroise Paré University Hospital
state: Hauts-de-Seine
city: Rennes
country: France
facility: University Hospital
state: Ille-et-Vilaine
city: Tours
country: France
facility: University Hospital
state: Indre-et-Loire
city: Grenoble
country: France
facility: University Hospital
state: Isère
city: Nancy
country: France
facility: University Hospital
state: Meuse
city: Lille
country: France
facility: University Hospital
state: Nord
city: Paris
country: France
facility: University Hospital of Saint-Louis
Study officials:
affiliation: Radiology Departement - University Hospital of Grenoble
name: Ivan Bricault, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Besançon
name: Eric Delabrousse, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bruno Lapuyade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Garches
name: Pascal Lacombe, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Lille
name: Laurent Lemaitre, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NANCY
name: Valérie Laurent, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Rennes
name: Jean-Yves Gauvrit, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tours
name: Olivier Favelle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Saint-Louis
name: Eric De Kerviler, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.