NCT00828893
Completed
Phase 2
Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT
AdministrateurCIC1 site in 1 country120 target enrollmentOctober 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Drainage
- Sponsor
- AdministrateurCIC
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.
Investigators
AdministrateurCIC
principal investigator
University Hospital, Grenoble
Eligibility 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
Outcomes
Primary Outcomes
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
Time Frame: 2 hours
Secondary Outcomes
- Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.(2 hours)
- Duration of intervention(3 hours)
- Dose irradiation and number of control scanners made(3 hours)
- overall satisfaction Score(3 hours)
- Success or failure of the final gesture made(3 hours)
- Number of attempts(3 hours)
- number of complications (per-operative, post-surgery)(7 days)
Study Sites (1)
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