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Completed

NCT Number: NCT01896219

CTNAV II : 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.

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Key information

Conditions

Drainage Ablation Biopsy Punction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Besançon, Doubs, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigation station (IMACTIS-CT®)

Device

Other names: Navigation station for gestures (carried out under CT) guidance

CT

Device

Reference method for gestures (carried out under CT) guidance

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Multicentric Evaluation of IMACTIS-CT Navigation System

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 11, 2013
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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