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Clinical Trials/NCT00828893
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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
January 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AdministrateurCIC
Responsible Party
Sponsor Investigator
Principal Investigator

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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