Light Needle Positioning Robot Under MRI Guidance

University Hospital, Grenoble20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Magnetic Resonance Imaging Robotic Surgical Procedures

Interventions

RobotDEVICE

Use of the robot to locate the fictional needle

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Grenoble

Grenoble, Isère, France

Outcomes

Primary Outcomes

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

Number of time in percentage of failed robot use.

evaluate the robot detection robustness

Time frame: 1hour20minutes

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

match of the robot fixation system

Time frame: 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).

device and software ergonomics

Time frame: 1hour20minutes

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

Device security

Time frame: 1hour20minutes

Data from ClinicalTrials.gov

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