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CompletedNCT02360241LPRobacusUpdated Nov 30, 2015

Light Needle Positioning Robot Under MRI Guidance

An interventional study of Robot in Magnetic Resonance Imaging and Robotic Surgical Procedures, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-30.

Sponsored by University Hospital, Grenoble · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Magnetic Resonance Imaging
  • Robotic Surgical Procedures
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 816 studies on the registry; 206 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Robot

    A robot will be used and it's position will be evaluated

    Device: Robot

Interventions

  • DeviceRobot

    Use of the robot to locate the fictional needle

06

What researchers measure

Primary outcomes

  1. 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).

    evaluate the real needle positioning precision: the robot effectiveness

    Time frame: 1hour20minutes

Secondary outcomes

  1. Number of time in percentage of failed robot use.

    evaluate the robot detection robustness

    Time frame: 1hour20minutes

  2. Number of time in percentage of failed fixation of the robot over the patient.

    match of the robot fixation system

    Time frame: 1hour20minutes

  3. 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).

    device and software ergonomics

    Time frame: 1hour20minutes

  4. Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use

    Device security

    Time frame: 1hour20minutes

07

Study locations

1 site
  • University Hospital Grenoble
    Grenoble, Isère 38043, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02360241
Lead sponsor
University Hospital, Grenoble
Collaborators
TIMC-IMAG
Responsible party
Sponsor
First posted
Feb 10, 2015
Start date
Feb 2015
Primary completion
Mar 2015
Completion
Oct 2015
Last update
Nov 30, 2015

Study contacts

Ivan Bricault, PhD, Pr
principal investigator · echipon@chu-grenoble.fr

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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