Navigation Guidance Gestures Carried Out Under CT - Full Text View

Navigation Guidance Gestures Carried Out Under CT (CT-Nav)

This study is not yet open for participant recruitment.

Verified by University Hospital, Grenoble, July 2009

First Received: January 23, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00828893

Purpose

The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.

Condition	Intervention	Phase
Drainage Biopsy Punction	Device: navigation station	Phase II Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Maximum distance between the planned trajectory and trajectory achieved by the needle puncture. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
Duration of intervention [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Dose irradiation and number of control scanners made [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
overall satisfaction Score [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Success or failure of the final gesture made [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Number of attempts [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
number of complications (per-operative, post-surgery) [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Intervention Details:

navigation station for gestures (carried out under CT) guidance

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828893

Contacts

Contact: Ivan Bricault, MD, PhD		KGuerrero@chu-grenoble.fr
Contact: Alexandre Moreau-Gaudry, MD, PhD		KGuerrero@chu-grenoble.fr

Locations

France
UniversityHospitalGrenoble
Grenoble, France

Sponsors and Collaborators

University Hospital, Grenoble

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital of Grenoble ( Ivan Bricault )
Study ID Numbers:	DCIC 08 01, IMACTIS company
Study First Received:	January 23, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00828893 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

drain under scanner

ClinicalTrials.gov processed this record on September 10, 2009