Light Needle Positioning Robot Under MRI Guidance

LPRobacus: Light Needle Positioning Robot Under MRI Guidance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02360241

Acronym

LPRobacus

Enrollment

Registered

2015-02-10

Start date

2015-02-28

Completion date

2015-10-31

Last updated

2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging, Robotic Surgical Procedures

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.

Interventions

DEVICERobot

Use of the robot to locate the fictional needle

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of time in percentage of failed robot use.	1hour20minutes	evaluate the robot detection robustness
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 that the robot was stopped (voluntary/dysfonctionnement) during its use	1hour20minutes	Device security

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026