Status:

COMPLETED

CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Lead Sponsor:

University Hospital, Grenoble

Conditions:

Drainage

Biopsy

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2016

Estimated Enrollment :

464 Patients enrolled

Trial Details

Trial ID

NCT01896219

Start Date

December 1 2013

End Date

September 1 2016

Last Update

January 2 2018

Active Locations (9)

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Page 1 of 3 (9 locations)

1

University Hospital

Besançon, Doubs, France, 25030

2

University Hospital

Bordeaux, Gironde, France, 33604

3

Ambroise Paré University Hospital

Boulogne-Billancourt, Hauts-de-Seine, France, 92100

4

University Hospital

Rennes, Ille-et-Vilaine, France, 35033