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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828893
First Posted: January 26, 2009
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT

Further study details as provided by AdministrateurCIC, 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 ]

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

Enrollment: 120
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: navigation station
    navigation station for gestures (carried out under CT) guidance
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • more or equal than 18 years old
  • patient affiliated to social security or similarly regime
  • patient sent to hospital for drain under CT

Exclusion Criteria:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  • Person under legal protection
  • Person participating in another clinical study
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00828893


Locations
France
UniversityHospitalGrenoble
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00828893     History of Changes
Other Study ID Numbers: DCIC 08 01
IMACTIS company
First Submitted: January 23, 2009
First Posted: January 26, 2009
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by AdministrateurCIC, University Hospital, Grenoble:
drain under scanner