Light Needle Positioning Robot Under MRI Guidance

NCT ID: NCT02360241

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Magnetic Resonance Imaging Robotic Surgical Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Robot

A robot will be used and it's position will be evaluated

Group Type EXPERIMENTAL

Robot

Intervention Type DEVICE

Use of the robot to locate the fictional needle

Interventions

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Robot

Use of the robot to locate the fictional needle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TIMC-IMAG

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan Bricault, PhD, Pr

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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University Hospital Grenoble

Grenoble, Isère, France

Site Status

Countries

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France

Related Links

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http://www.cic-it-grenoble.fr/

Website of the Grenoble clinical investigation center - Technological Innovation

http://www-timc.imag.fr/

Website of TIMC-IMAG laboratory

Other Identifiers

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DCIC 14-36

Identifier Type: -

Identifier Source: org_study_id