CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System
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ClinicalTrials.gov Identifier: NCT01896219 |
Recruitment Status :
Completed
First Posted : July 11, 2013
Last Update Posted : January 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Drainage Biopsy Punction Ablation | Device: Navigation station (IMACTIS-CT®) Device: CT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 464 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Multicentric Evaluation of IMACTIS-CT Navigation System |
Actual Study Start Date : | December 2013 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | September 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Gesture performed under control tomodensitometric (CT)
Conventional
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Device: CT
Reference method for gestures (carried out under CT) guidance |
Experimental: Gesture performed under Navigation-assisted procedure (NAV)
Use of the IMACTIS-CT® Navigation System
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Device: Navigation station (IMACTIS-CT®)
Other Name: Navigation station for gestures (carried out under CT) guidance |
- 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
- Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method. [ Time Frame: 2 hours ]
- Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture. [ Time Frame: 2 hours ]Scale of quantitative satisfaction
- Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture. [ Time Frame: 2 hours ]
- 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 ]
- Evaluation of the navigation system use by the operators, based on needle holder localization files [ Time Frame: 2 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896219
France | |
University Hospital | |
Besançon, Doubs, France, 25030 | |
University Hospital | |
Bordeaux, Gironde, France, 33604 | |
Ambroise Paré University Hospital | |
Boulogne Billancourt, Hauts-de-Seine, France, 92100 | |
University Hospital | |
Rennes, Ille-et-Vilaine, France, 35033 | |
University Hospital | |
Tours, Indre-et-Loire, France, 37044 | |
University Hospital | |
Grenoble, Isère, France, 38043 | |
University Hospital | |
Nancy, Meuse, France, 54511 | |
University Hospital | |
Lille, Nord, France, 59037 | |
University Hospital of Saint-Louis | |
Paris, France, 75475 |
Principal Investigator: | 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 of 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 |
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT01896219 |
Other Study ID Numbers: |
DCIC 12 29 2013-A00539-36 ( Other Identifier: IDRCB ) |
First Posted: | July 11, 2013 Key Record Dates |
Last Update Posted: | January 2, 2018 |
Last Verified: | December 2017 |
Medical device CT Needle Navigation |
IMACTIS-CT® Thoraco-abdominal level anesthesia needles |