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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00828893 |
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Date of registration:
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23/01/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Navigation Guidance Gestures Carried Out Under CT
CT-Nav |
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Scientific title:
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Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00828893 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Biopsy
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Drainage
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Punction
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Intervention(s)
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Device: navigation station
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Primary Outcome(s)
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Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
[Time Frame: 2 hours]
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Secondary Outcome(s)
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overall satisfaction Score
[Time Frame: 3 hours]
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Dose irradiation and number of control scanners made
[Time Frame: 3 hours]
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Duration of intervention
[Time Frame: 3 hours]
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Success or failure of the final gesture made
[Time Frame: 3 hours]
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Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.
[Time Frame: 2 hours]
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Number of attempts
[Time Frame: 3 hours]
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number of complications (per-operative, post-surgery)
[Time Frame: 7 days]
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Secondary ID(s)
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IMACTIS company
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DCIC 08 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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