Light Needle Positioning Robot Under MRI Guidance | NCT02360241

Studies
Light Needle Positioning Robot Under MRI Guidance

NCT02360241

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Nov 30, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Magnetic Resonance Imaging
Robotic Surgical Procedures

Interventions

Robot

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Mar 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jan 12, 2015

First Submission Date that Met QC Criteria

Feb 4, 2015

First Posted Date

Feb 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Name	Class
TIMC-IMAG	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robot	Experimental	A robot will be used and it's position will be evaluated	Device: Robot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot	Device	Use of the robot to locate the fictional needle	Robot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of time in percentage of failed robot use.	evaluate the robot detection robustness	1hour20minutes
Number of time in percentage of failed fixation of the robot over the patient.	match of the robot fixation system

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ivan Bricault, PhD, Pr	echipon@chu-grenoble.fr	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Grenoble		Grenoble	Isère	38043	France

References Module

Citations

Not provided

Label	URL
Website of the Grenoble clinical investigation center - Technological Innovation	View source
Website of TIMC-IMAG laboratory	View source

ID	Term
D025321	Surgery, Computer-Assisted
D013514	Surgical Procedures, Operative
D012371	Robotics
D001331	Automation