DrainageNCT01896219

CTNAV II : Multicentric Evaluation of IMACTIS-CT Navigation System

A study testing Navigation station (IMACTIS-CT®) and CT in people with Drainage and Biopsy, run by University Hospital, Grenoble at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Estimate the medical service of a system of navigation (IMACTIS-CT®)in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during gestures of interventional radiology under scan in the thoraco-abdominal level. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Drainage, Biopsy, Punction
What is being tested?: Navigation station (IMACTIS-CT®) and CT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 464 participants
Where: 9 sitesFrance
Study dates: Dec 2013to Sep 2016
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
No healthy volunteers
Adult, Older adult

Who may be able to join

More or equal the 18 years old
Patient for whom an indication of diagnostic or therapeutic percutaneous interventional gesture in the thoraco-abdominal level under CT guidance is prescribed
Patient affiliated to social security or similarly regime
Patient signed consent for participation in the study.

Who cannot join

Patient with a medical device using a magnetic field (eg, patient with a pacemaker)
Patient who presents ferromagnetic foreign bodies intracorporeal close to the working zone of Radiologist, and that can interact with the medical device
Pregnant women and lactating mothers
Ward of court or under guardianship
Person deprived of freedom by judicial or administrative decision
Person under legal protection

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

France9 sites

University Hospital
Besançon, Doubs, 25030
University Hospital
Bordeaux, Gironde, 33604
Ambroise Paré University Hospital
Boulogne-Billancourt, Hauts-de-Seine, 92100
University Hospital
Grenoble, Isère, 38043
University Hospital
Lille, Nord, 59037
University Hospital
Nancy, Meuse, 54511
University Hospital of Saint-Louis
Paris, 75475
University Hospital
Rennes, Ille-et-Vilaine, 35033
University Hospital
Tours, Indre-et-Loire, 37044

Other trials in France

About this study

Official title: Multicentric Evaluation of IMACTIS-CT Navigation System

Conditions: Drainage, Biopsy, Punction, Ablation
Being tested: Navigation station (IMACTIS-CT®), CT
Keywords: Medical device, CT, Needle, Navigation, IMACTIS-CT®, Thoraco-abdominal level, anesthesia needles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Navigation station (IMACTIS-CT®)Device
Also called Navigation station for gestures (carried out under CT) guidance
CTDevice
Reference method for gestures (carried out under CT) guidance

Study groups in NCT01896219
Study group	Role	What they receive
Gesture performed under control tomodensitometric (CT)	Active comparator	Conventional Receives: Device: CT
Gesture performed under Navigation-assisted procedure (NAV)	Experimental	Use of the IMACTIS-CT® Navigation System Receives: Device: Navigation station (IMACTIS-CT®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimate the medical service of a system of navigation (IMACTIS-CT ®) in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during interventional radiology gestures
Three criteria are estimated:
- Safety: number of major complications (due to gesture)
- Efficiency: number of targets achieved
- Performance: number of scancontrol made during the puncture
Measured: 2 hours

Secondary outcomes (5)

Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.
Measured: 2 hours
Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.
Scale of quantitative satisfaction
Measured: 2 hours
Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.
Measured: 2 hours
Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture
Measured: 2 hours
Evaluation of the navigation system use by the operators, based on needle holder localization files
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Sep 2016

First posted11 Jul 2013 (estimated)
Study startDec 2013
Primary completionJul 2015
Study completionSep 2016

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 N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01896219
Sponsor's protocol ID: DCIC 12 29
Other IDs: 2013-A00539-36
Status last verified: Dec 2017
First submitted: 5 Jul 2013
Last updated: 2 Jan 2018
Results posted: No
Data monitoring committee: No

Publications

Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.
PubMed 28683837

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Drainage trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentric Evaluation of IMACTIS-CT Navigation System
ClinicalTrials.gov ID: NCT01896219
Acronym / sponsor ID: DCIC 12 29
Conditions: Drainage, Biopsy, Punction, Ablation
Keywords: Medical device, CT, Needle, Navigation, IMACTIS-CT®, Thoraco-abdominal level, anesthesia needles
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: Dec 2013 (actual)
Primary completion: Jul 2015 (actual)
Study completion: Sep 2016 (actual)
First posted: 11 Jul 2013 (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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gesture performed under control tomodensitometric (CT)	Active comparator	Device: CTConventional
Gesture performed under Navigation-assisted procedure (NAV)	Experimental	Device: Navigation station (IMACTIS-CT®)Use of the IMACTIS-CT® Navigation System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

More or equal the 18 years old
Patient for whom an indication of diagnostic or therapeutic percutaneous interventional gesture in the thoraco-abdominal level under CT guidance is prescribed
Patient affiliated to social security or similarly regime
Patient signed consent for participation in the study.

Key exclusion criteria (6 listed)

Patient with a medical device using a magnetic field (eg, patient with a pacemaker)
Patient who presents ferromagnetic foreign bodies intracorporeal close to the working zone of Radiologist, and that can interact with the medical device
Pregnant women and lactating mothers
Ward of court or under guardianship
Person deprived of freedom by judicial or administrative decision

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 station (IMACTIS-CT®)Also: Navigation station for gestures (carried out under CT) guidance	Device	Gesture performed under Navigation-assisted procedure (NAV)
CTReference method for gestures (carried out under CT) guidance	Device	Gesture performed under control tomodensitometric (CT)

Primary outcome

Estimate the medical service of a system of navigation (IMACTIS-CT ®) in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during interventional radiology gestures
Time frame: 2 hours
Three criteria are estimated: * Safety: number of major complications (due to gesture) * Efficiency: number of targets achieved * Performance: number of scancontrol made during the puncture

5 secondary outcomes

Comparison of the duration of needle setting up procedure between IMACTIS-CT® and the reference method.
Time frame: 2 hours
Comparison (IMACTIS-CT ® vs References) of the operator satisfaction during his gesture.
Time frame: 2 hours
Comparison (IMACTIS-CT ® vs. Reference) of the radiation dose delivered during the puncture.
Time frame: 2 hours
Evaluation of delivered medical service by carrying out a sub-group analysis according to the stratification of the difficulty of gesture
Time frame: 2 hours
Evaluation of the navigation system use by the operators, based on needle holder localization files
Time frame: 2 hours

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 2 Jan 2018.
Derived from this study: PubMed 28683837Rouchy RC, Moreau-Gaudry A, Chipon E, Aubry S, Pazart L, Lapuyade B, Durand M, Hajjam M, Pottier S, Renard B, Logier R, Orry X, Cherifi A, Quehen E, Kervio G, Favelle O, Patat F, De Kerviler E, Hughes C, Medici M, Ghelfi J, Mounier A, Bricault I. Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial. Trials. 2017 Jul 6;18(1):306. doi: 10.1186/s13063-017-2049-6.

Related trials for Drainage

Not yet recruitingObservational study
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement
ACDF Surgery
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruitingObservational study
Therapeutic Outcomes of In-Hospital Resuscitation of Patients Admitted to the Internal Medicine Wards
Survival to Discharge With Good Neurologic Outcome Among in Hospital Cardiac Arrest Patients

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, Pr principal investigator

Radiology Departement - University Hospital of Grenoble

Eric Delabrousse, Pr principal investigator

University Hospital of Besançon

Bruno Lapuyade, MD principal investigator

University Hospital, Bordeaux

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Navigation station (IMACTIS-CT®) and CT in people with Drainage and Biopsy, run by University Hospital, Grenoble at 9 sites 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 4 inclusion and 6 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Estimate the medical service of a system of navigation (IMACTIS-CT ®) in terms of SAFETY, EFFICIENCY and PERFORMANCE, in comparison with the reference method during interventional radiology gestures (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 NCT01896219, 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 2 Jan 2018.