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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00828893
First received: January 23, 2009
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828893

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00828893     History of Changes
Other Study ID Numbers: DCIC 08 01, IMACTIS company
Study First Received: January 23, 2009
Last Updated: February 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
drain under scanner

ClinicalTrials.gov processed this record on May 16, 2013