NCT00828893

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

January 23, 2009

Last Update Submit

February 17, 2012

Conditions

DrainageBiopsyPunction

Keywords

drain under scanner

Outcome Measures

Primary Outcomes (1)

  • Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.

    2 hours

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

navigation stationDEVICE

navigation station for gestures (carried out under CT) guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more or equal than 18 years old
  • patient affiliated to social security or similarly regime
  • patient sent to hospital for drain under CT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospitalGrenoble

Grenoble, France

Location

Related Publications (1)

  • Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.

    PMID: 23988636DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

FR(1)