Light Needle Positioning Robot Under MRI Guidance

Magnetic Resonance Imaging Clinical Trial

— LPRobacus  

Official title:

LPRobacus: Light Needle Positioning Robot Under MRI Guidance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360241
• Other study ID #: DCIC 14-36
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: November 27, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Robotic Surgical Procedures

Intervention

Device:
• Robot
Use of the robot to locate the fictional needle

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of time in percentage of failed robot use.	evaluate the robot detection robustness	1hour20minutes	No
Secondary	Number of time in percentage of failed fixation of the robot over the patient.	match of the robot fixation system	1hour20minutes	No
Secondary	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	1hour20minutes	No
Secondary	Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use	Device security	1hour20minutes	No

External Links

•   Website of the Grenoble clinical investigation center - Technological Innovation
•   Website of TIMC-IMAG laboratory