Navigation Guidance Gestures Carried Out Under CT

Phase 2

Completed

• Conditions: Drainage; Biopsy; Punction

• Registration Number: NCT00828893
• Lead Sponsor: AdministrateurCIC

Brief Summary

The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Study Start: 2009-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.	2 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 Grenoble, France