DrainagePhase 2/3CT-NavNCT00828893
Navigation Guidance Gestures Carried Out Under CT
A Phase 2/3 study testing navigation station in people with Drainage and Biopsy, run by AdministrateurCIC at 1 site in France.
Trial summary
The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- navigation station
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jan 2012
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- patient sent to hospital for drain under CT
Who cannot join
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Person participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT
The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.
- Being tested
- navigation station
- Keywords
- drain under scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navigation stationDevice
navigation station for gestures (carried out under CT) guidance
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
Measured: 2 hours
Secondary outcomes (7)
Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.
Measured: 2 hours
Duration of intervention
Measured: 3 hours
Dose irradiation and number of control scanners made
Measured: 3 hours
overall satisfaction Score
Measured: 3 hours
Success or failure of the final gesture made
Measured: 3 hours
Number of attempts
Measured: 3 hours
number of complications (per-operative, post-surgery)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DrainageStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828893
- Sponsor's protocol ID
- DCIC 08 01
- Other IDs
- IMACTIS company
- Acronym
- CT-Nav
- Status last verified
- Feb 2012
- First submitted
- 23 Jan 2009
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.
PubMed 23988636
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Use of a Navigation Guidance Gestures Carried Out Under CT
- ClinicalTrials.gov ID
- NCT00828893
- Acronym / sponsor ID
- CT-Nav / DCIC 08 01
- Keywords
- drain under scanner
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jan 2009 (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.
The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- patient sent to hospital for drain under CT
Key exclusion criteria (7 listed)
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
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 |
|---|---|---|
| navigation stationnavigation station for gestures (carried out under CT) guidance | Device | – |
Primary outcome
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia.
Time frame: 2 hours
7 secondary outcomes
Maximum distance between the planned trajectory and trajectory achieved by the needle puncture.
Time frame: 2 hours
Duration of intervention
Time frame: 3 hours
Dose irradiation and number of control scanners made
Time frame: 3 hours
overall satisfaction Score
Time frame: 3 hours
Success or failure of the final gesture made
Time frame: 3 hours
Number of attempts
Time frame: 3 hours
number of complications (per-operative, post-surgery)
Time frame: 7 days
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 20 Feb 2012.
- Derived from this study: PubMed 23988636Robert AL, Chagnon G, Bricault I, Cinquin P, Moreau-Gaudry A. A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue. J Mech Behav Biomed Mater. 2013 Dec;28:156-70. doi: 10.1016/j.jmbbm.2013.07.023. Epub 2013 Aug 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing navigation station in people with Drainage and Biopsy, run by AdministrateurCIC 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 3 inclusion and 7 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 20 Feb 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum distance between the planned trajectory and trajectory achieved, defined for the needle of local anesthesia. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828893, which also lists 1 linked publication.
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 20 Feb 2012.