Light Needle Positioning Robot Under MRI Guidance (LPRobacus)

November 27, 2015 updated by: University Hospital, Grenoble

LPRobacus: Light Needle Positioning Robot Under MRI Guidance

This study aim is to evaluate the needle positioning precision, compared to the real path planned by the physician on healthy voluntaries, by positioning a fictional needle, without inserting it.

Additionally, this study will evaluate:

  • the robot precision,
  • the robot detection robustness,
  • the software and device ergonomics,
  • the device security.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • person over 18 years old,
  • person with height is under 1m90,
  • person with abdomen height is under 28 cm,
  • person with abdomen width is between 26 cm to 50 cm,
  • person able to hold his breath during 30 seconds,
  • person affiliated to social security or similarly regime,
  • signed consent for participation in the study.

Exclusion Criteria:

  • person with a contraindication for abdomen MRI,
  • claustrophobic person,
  • protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot
A robot will be used and it's position will be evaluated
Device: Robot
Use of the robot to locate the fictional needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of needle positioning needed to reach the real path wanted, with a 5mm precision (cylinder diameter including the path defined by the two skin marker and the need axe).
Time Frame: 1hour20minutes
evaluate the real needle positioning precision: the robot effectiveness
1hour20minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of time in percentage of failed robot use.
Time Frame: 1hour20minutes
evaluate the robot detection robustness
1hour20minutes
Number of time in percentage of failed fixation of the robot over the patient.
Time Frame: 1hour20minutes
match of the robot fixation system
1hour20minutes
Score from a qualitative evaluation scale of the healthy voluntary discomfort during robot use and the score from a scale of the physician satisfaction (girth, ease, speed).
Time Frame: 1hour20minutes
device and software ergonomics
1hour20minutes
Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use
Time Frame: 1hour20minutes
Device security
1hour20minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

TIMC-IMAG

Investigators

  • Principal Investigator: Ivan Bricault, PhD, Pr, echipon@chu-grenoble.fr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • DCIC 14-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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