CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Not Applicable

Completed

• Conditions: Biopsy; Punction; Ablation; Drainage
• Interventions: Device: Navigation station (IMACTIS-CT®); Device: CT

• Registration Number: NCT01896219
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-05
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-11
• Study Start: 2013-12
• Primary Completion: 2015-07
• Study Completion: 2016-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gesture performed under Navigation-assisted procedure (NAV)	Navigation station (IMACTIS-CT®)	Use of the IMACTIS-CT® Navigation System
Gesture performed under control tomodensitometric (CT)	CT	Conventional

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.	2 hours	Scale of quantitative satisfaction
Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.	2 hours
Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture	2 hours
Evaluation of the navigation system use by the operators, based on needle holder localization files	2 hours
Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.	2 hours

Trial Locations

Locations (3)

Ambroise Paré University Hospital; 🇫🇷 Boulogne Billancourt, Hauts-de-Seine, France

University Hospital; 🇫🇷 Lille, Nord, France

University Hospital of Saint-Louis; 🇫🇷 Paris, France