CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

Ablation Clinical Trial

Official title:

Multicentric Evaluation of IMACTIS-CT Navigation System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896219
• Other study ID #: DCIC 12 29
• Secondary ID: 2013-A00539-36
• Status: Completed
• Phase: N/A
• First received: July 5, 2013
• Last updated: December 29, 2017
• Start date: December 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: September 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ablation
• Biopsy
• Drainage
• Punction

Intervention

Device:
• Navigation station (IMACTIS-CT®)

• CT
Reference method for gestures (carried out under CT) guidance

Locations

Country	Name	City	State
France	University Hospital	Besançon	Doubs
France	University Hospital	Bordeaux	Gironde
France	Ambroise Paré University Hospital	Boulogne Billancourt	Hauts-de-Seine
France	University Hospital	Grenoble	Isère
France	University Hospital	Lille	Nord
France	University Hospital	Nancy	Meuse
France	University Hospital of Saint-Louis	Paris
France	University Hospital	Rennes	Ille-et-Vilaine
France	University Hospital	Tours	Indre-et-Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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