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CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

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ClinicalTrials.gov Identifier: NCT01896219
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drainage Biopsy Punction Ablation Device: Navigation station (IMACTIS-CT®) Device: CT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicentric Evaluation of IMACTIS-CT Navigation System
Actual Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gesture performed under control tomodensitometric (CT)
Conventional
 Device: CT
Reference method for gestures (carried out under CT) guidance
Experimental: Gesture performed under Navigation-assisted procedure (NAV)
Use of the IMACTIS-CT® Navigation System
 Device: Navigation station (IMACTIS-CT®)
Other Name: Navigation station for gestures (carried out under CT) guidance


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 Outcome Measures :
  1. Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method. [ Time Frame: 2 hours ]
  2. Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture. [ Time Frame: 2 hours ]
    Scale of quantitative satisfaction

  3. Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture. [ Time Frame: 2 hours ]
  4. Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture [ Time Frame: 2 hours ]
  5. Evaluation of the navigation system use by the operators, based on needle holder localization files [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896219


Locations
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France
University Hospital
Besançon, Doubs, France, 25030
University Hospital
Bordeaux, Gironde, France, 33604
Ambroise Paré University Hospital
Boulogne Billancourt, Hauts-de-Seine, France, 92100
University Hospital
Rennes, Ille-et-Vilaine, France, 35033
University Hospital
Tours, Indre-et-Loire, France, 37044
University Hospital
Grenoble, Isère, France, 38043
University Hospital
Nancy, Meuse, France, 54511
University Hospital
Lille, Nord, France, 59037
University Hospital of Saint-Louis
Paris, France, 75475
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: 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 of Bordeaux
Principal Investigator: Pascal Lacombe, Pr University Hospital of Garches
Principal Investigator: Laurent Lemaitre, Pr University Hospital of Lille
Principal Investigator: Valérie Laurent, Pr CHU Nancy
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01896219    
Other Study ID Numbers: DCIC 12 29
2013-A00539-36 ( Other Identifier: IDRCB )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Keywords provided by University Hospital, Grenoble:
Medical device
CT
Needle
Navigation
 IMACTIS-CT®
Thoraco-abdominal level
anesthesia needles