CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Drainage Biopsy Punction Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gesture performed under control tomodensitometric (CT)

Conventional

Group Type ACTIVE_COMPARATOR

CT

Intervention Type DEVICE

Reference method for gestures (carried out under CT) guidance

Gesture performed under Navigation-assisted procedure (NAV)

Use of the IMACTIS-CT® Navigation System

Group Type EXPERIMENTAL

Navigation station (IMACTIS-CT®)

Intervention Type DEVICE

Interventions

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Navigation station (IMACTIS-CT®)

Intervention Type DEVICE

CT

Reference method for gestures (carried out under CT) guidance

Intervention Type DEVICE

Other Intervention Names

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Navigation station for gestures (carried out under CT) guidance

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No