Light Needle Positioning Robot Under MRI Guidance
LPRobacus
LPRobacus: Light Needle Positioning Robot Under MRI Guidance
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 30, 2015
October 1, 2015
28 days
January 12, 2015
November 27, 2015
Conditions
Outcome Measures
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
1hour20minutes
Secondary Outcomes (4)
Number of time in percentage of failed robot use.
1hour20minutes
Number of time in percentage of failed fixation of the robot over the patient.
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).
1hour20minutes
Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use
1hour20minutes
Study Arms (1)
Robot
EXPERIMENTALA robot will be used and it's position will be evaluated
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- TIMC-IMAGcollaborator
Study Sites (1)
University Hospital Grenoble
Grenoble, Isère, 38043, France
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivan Bricault, PhD, Pr
echipon@chu-grenoble.fr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2015
First Posted
February 10, 2015
Study Start
February 1, 2015
Primary Completion
March 1, 2015
Study Completion
October 1, 2015
Last Updated
November 30, 2015
Record last verified: 2015-10