CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

December 29, 2017 updated by: University Hospital, Grenoble

Multicentric Evaluation of IMACTIS-CT Navigation System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

464

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75475
        • University Hospital of Saint-Louis
    • Doubs
      • Besançon, Doubs, France, 25030
        • University Hospital
    • Gironde
      • Bordeaux, Gironde, France, 33604
        • University Hospital
    • Hauts-de-Seine
      • Boulogne Billancourt, Hauts-de-Seine, France, 92100
        • Ambroise Paré university Hospital
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • University Hospital
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • University Hospital
    • Isère
      • Grenoble, Isère, France, 38043
        • University Hospital
    • Meuse
      • Nancy, Meuse, France, 54511
        • University Hospital
    • Nord
      • Lille, Nord, France, 59037
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Navigation station for gestures (carried out under CT) guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.
Time Frame: 2 hours
2 hours
Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.
Time Frame: 2 hours
Scale of quantitative satisfaction
2 hours
Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.
Time Frame: 2 hours
2 hours
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
2 hours
Evaluation of the navigation system use by the operators, based on needle holder localization files
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Ivan Bricault, Pr, Radiology Departement - University Hospital of Grenoble
  • Principal Investigator: Eric Delabrousse, Pr, University Hospital of Besancon
  • 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, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCIC 12 29
  • 2013-A00539-36 (OTHER: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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