Magnetic Resonance ImagingLPRobacusNCT02360241
Light Needle Positioning Robot Under MRI Guidance
A study testing Robot in people with Magnetic Resonance Imaging and Robotic Surgical Procedures, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Robotic Surgical Procedures
- What is being tested?
- Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LPRobacus: Light Needle Positioning Robot Under MRI Guidance
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.
- Being tested
- Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotDevice
Use of the robot to locate the fictional needle
| Study group | Role | What they receive |
|---|---|---|
| Robot | Experimental | A robot will be used and it's position will be evaluated Receives: Device: Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1hour20minutes
Secondary outcomes (4)
Number of time in percentage of failed robot use.
evaluate the robot detection robustness
Measured: 1hour20minutes
Number of time in percentage of failed fixation of the robot over the patient.
match of the robot fixation system
Measured: 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).
device and software ergonomics
Measured: 1hour20minutes
Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use
Device security
Measured: 1hour20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG
- Responsible party
- Sponsor
- Investigators
- Ivan Bricault, PhD, Pr, Principal investigator, echipon@chu-grenoble.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360241
- Sponsor's protocol ID
- DCIC 14-36
- Acronym
- LPRobacus
- Status last verified
- Oct 2015
- First submitted
- 12 Jan 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LPRobacus: Light Needle Positioning Robot Under MRI Guidance
- ClinicalTrials.gov ID
- NCT02360241
- Acronym / sponsor ID
- LPRobacus / DCIC 14-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot | Experimental | Device: RobotA robot will be used and it's position will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RobotUse of the robot to locate the fictional needle | Device | Robot |
Primary outcome
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).
Time frame: 1hour20minutes
evaluate the real needle positioning precision: the robot effectiveness
4 secondary outcomes
Number of time in percentage of failed robot use.
Time frame: 1hour20minutes
Number of time in percentage of failed fixation of the robot over the patient.
Time frame: 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).
Time frame: 1hour20minutes
Number of time in percentage that the robot was stopped (voluntary/dysfonctionnement) during its use
Time frame: 1hour20minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Website of the Grenoble clinical investigation center - Technological InnovationLink provided by the sponsor.
- Website of TIMC-IMAG laboratoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Bricault, PhD, Pr principal investigator
echipon@chu-grenoble.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot in people with Magnetic Resonance Imaging and Robotic Surgical Procedures, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 1hour20minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.