CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

NCT01896219 | Completed

• 2 other identifiers: DCIC 12 292013-A00539-36
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 9

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.

Conditions

Drainage; Biopsy; Punction; Ablation

Keywords

Medical device; CT; Needle; Navigation; IMACTIS-CT®; Thoraco-abdominal level; anesthesia needles

Outcome Measures

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

  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 Outcomes (5)

• Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.

  2 hours

• Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.

  2 hours

• 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

Study Arms (2)

Gesture performed under control tomodensitometric (CT)

ACTIVE COMPARATOR

Conventional

Device: CT

Gesture performed under Navigation-assisted procedure (NAV)

EXPERIMENTAL

Use of the IMACTIS-CT® Navigation System

Device: Navigation station (IMACTIS-CT®)

Interventions

Navigation station (IMACTIS-CT®) DEVICE

Also known as: Navigation station for gestures (carried out under CT) guidance

Gesture performed under Navigation-assisted procedure (NAV)

CT DEVICE

Reference method for gestures (carried out under CT) guidance

Gesture performed under control tomodensitometric (CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (9)

University Hospital

Besançon, Doubs, 25030, France

Location

University Hospital

Bordeaux, Gironde, 33604, France

Location

Ambroise Paré University Hospital

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

Location

University Hospital

Rennes, Ille-et-Vilaine, 35033, France

Location

University Hospital

Tours, Indre-et-Loire, 37044, France

Location

University Hospital

Grenoble, Isère, 38043, France

Location

University Hospital

Nancy, Meuse, 54511, France

Location

University Hospital

Lille, Nord, 59037, France

Location

University Hospital of Saint-Louis

Paris, 75475, France

Location

Related Publications (1)

• Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.

  PMID: 28683837 DERIVED

Study Officials

• Ivan Bricault, Pr

  Radiology Departement - University Hospital of Grenoble

  PRINCIPAL INVESTIGATOR

• Eric Delabrousse, Pr

  University Hospital of Besançon

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: July 11, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2016
• Last Updated: January 2, 2018

Record last verified: 2017-12

Locations

FR (9)