Light Needle Positioning Robot Under MRI Guidance

Not Applicable

Completed

• Conditions: Magnetic Resonance Imaging; Robotic Surgical Procedures
• Interventions: Device: Robot

• Registration Number: NCT02360241
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-12
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Primary Completion: 2015-03
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot	Robot	A robot will be used and it's position will be evaluated

Primary Outcome Measures

Name	Time	Method
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).	1hour20minutes	evaluate the real needle positioning precision: the robot effectiveness

Secondary Outcome Measures

Name	Time	Method
Number of time in percentage of failed fixation of the robot over the patient.	1hour20minutes	match of the robot fixation system
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).	1hour20minutes	device and software ergonomics
Number of time in percentage of failed robot use.	1hour20minutes	evaluate the robot detection robustness
Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use	1hour20minutes	Device security

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, Isère, France