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Completed

NCT Number: NCT02360241

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.

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Key information

Conditions

Magnetic Resonance Imaging Robotic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, Isère, 38043, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot

Device

Use of the robot to locate the fictional needle

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).

    Time frame: 1hour20minutes

    evaluate the real needle positioning precision: the robot effectiveness

Secondary outcomes

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

    Time frame: 1hour20minutes

    evaluate the robot detection robustness

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

    Time frame: 1hour20minutes

    match of the robot fixation system

  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).

    Time frame: 1hour20minutes

    device and software ergonomics

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

    Time frame: 1hour20minutes

    Device security

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • TIMC-IMAG

Registry information

Official study title

LPRobacus: Light Needle Positioning Robot Under MRI Guidance

Acronym: LPRobacus

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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