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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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