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IMACTIS CT-NAVIGATION - CLINICAL EVALUATION

Clinical study CT-NAV I - Increased accuracy and fewer controls

IMACTIS CT-Navigation was successfully validated during a comparative, prospective, randomized clinical study on 120 patients at the Grenoble University Hospital on various procedures (drainage, biopsy, tumor ablation, infiltration, sympathicolysis).

The clinical study shows, that when compared to conventional procedures, the use of IMACTIS leads to:

  • Increased accuracy (gain in distance and angle accuracy higher than 50%)
  • Fewer controls are necessary to reach the target.


Publication

Computer assisted electromagnetic navigation improves accuracy in computed tomography guided interventions: A prospective randomized clinical trial. P. Durand, A. Moreau-Gaudry, A. Silvent, J. Frandon, E. Chipon, M. Medici, I. Bricault.
PLoS One, March, 15, 2017.

Clinical study CT-NAV II

Clinical study CT-NAV II is a multicentric, comparative, prospective and randomized clinical study. It took place in 9 French publics hospitals, more than 450 patients were enrolled.
The aim of this trial is to evaluate the clinical benefit of the navigation system by comparing the results obtained in the navigation-assisted group with those obtained in the conventional group during CT-guided procedures.
Three criterias are used:

  • Safety: The number of AEs that are considered to be major.
  • Efficacy: The number of targets reached
  • Performance: The number of control scans acquired during the needle insertion.


Publication of study protocol

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. RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle, F. Patat, E. De Kerviler, C. Hughes, M. Medici, J. Ghelfi, A. Mounier and I. Bricault.
Trials, July, 6, 2017.