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
  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:
No publications provided by University Hospital, Grenoble

Additional 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
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 April 16, 2014