Central Venous CathetersNEEDLE-VISIONCT04463147
Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique
A study testing Needle-pilotTM device in people with Central Venous Catheters and Ultrasound Guidance, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheters, Ultrasound Guidance
- What is being tested?
- Needle-pilotTM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 31 Dec 2021
- 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
- all residents and practicioners of intensive care units in the Nîmes University Hospital, France.
Who cannot join
- unavailability or operator refusal, and more than one year without subclavian central catheterization (for experienced subgroup).
Trial locations and contacts
1 site in 1 country.
About this study
Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex as compared to jugular site2,3. New magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a better needle visualisation and a better success rate. The investigators hypothesize that such device could improve the feasibility of subclavian catheterism. As this device has not been evaluated in patients, the investigators decided to perform a simulation study on a human torso mannequin. This methodology has been already used by Vogel et al in 20154. The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilot™ device.
- Conditions
- Central Venous Catheters, Ultrasound Guidance
- Being tested
- Needle-pilotTM device
- Keywords
- Catheterization, Subclavian Vein, Vascular Access Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-pilotTM deviceDevice
The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.
| Study group | Role | What they receive |
|---|---|---|
| new residents | Other | new residents in ultrasound-guided central vascular catheterization. Receives: Device: Needle-pilotTM device |
| experienced residents or ICU practitioners | Other | experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization. Receives: Device: Needle-pilotTM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
First puncture success delay
comparison of time (in seconds) between first puncture and successful "blood-aspiration" on a "subclavian venous" torso mannequin.
Measured: during the procedure
Secondary outcomes (4)
Failure Rate
Failure is defined as a puncture time > 300 seconds. The criterion corresponds to an absolute value: failure or not
Measured: during the procedure
Cutaneous wall
Counting the number of times each participant will puncture the wall of the mannequin before succeeding in puncturing the vessel with the 2 techniques and comparing this number between groups.
Measured: during the procedure
Posterior wall
Number of posterior vessel wall penetration
Measured: during the procedure
Puncture comfort
Operator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Nov 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Central Venous CathetersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463147
- Sponsor's protocol ID
- LOCAL/2019/AC-01
- Acronym
- NEEDLE-VISIO
- Status last verified
- Aug 2021
- First submitted
- 14 Feb 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grau-Mercier L, Chetioui A, Muller L, Roger C, Genre Grandpierre R, de La Coussaye JE, Cuvillon P, Claret PG, Bobbia X. Magnetic needle-tracking device for ultrasound guidance of radial artery puncture: A randomized study on a simulation model. J Clin Ultrasound. 2021 Mar;49(3):212-217. doi: 10.1002/jcu.22945. Epub 2020 Nov 16.
PubMed 33196110
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique
- ClinicalTrials.gov ID
- NCT04463147
- Acronym / sponsor ID
- NEEDLE-VISIO / LOCAL/2019/AC-01
- Conditions
- Central Venous Catheters, Ultrasound Guidance
- Keywords
- Catheterization, Subclavian Vein, Vascular Access Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- 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.
Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex as compared to jugular site2,3. New magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a better needle visualisation and a better success rate. The investigators hypothesize that such device could improve the feasibility of subclavian catheterism. As this device has not been evaluated in patients, the investigators decided to perform a simulation study on a human torso mannequin. This methodology has been already used by Vogel et al in 20154. The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilot™ device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new residents | Other | Device: Needle-pilotTM devicenew residents in ultrasound-guided central vascular catheterization. |
| experienced residents or ICU practitioners | Other | Device: Needle-pilotTM deviceexperienced residents or ICU practitioners in ultrasound-guided central vascular catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all residents and practicioners of intensive care units in the Nîmes University Hospital, France.
Key exclusion criteria (1 listed)
- unavailability or operator refusal, and more than one year without subclavian central catheterization (for experienced subgroup).
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 |
|---|---|---|
| Needle-pilotTM deviceThe main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device. | Device | experienced residents or ICU practitioners, new residents |
Primary outcome
First puncture success delay
Time frame: during the procedure
comparison of time (in seconds) between first puncture and successful "blood-aspiration" on a "subclavian venous" torso mannequin.
4 secondary outcomes
Failure Rate
Time frame: during the procedure
Cutaneous wall
Time frame: during the procedure
Posterior wall
Time frame: during the procedure
Puncture comfort
Time frame: immediately after the procedure
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 4 Dec 2025.
- Results publication: PubMed 33196110Grau-Mercier L, Chetioui A, Muller L, Roger C, Genre Grandpierre R, de La Coussaye JE, Cuvillon P, Claret PG, Bobbia X. Magnetic needle-tracking device for ultrasound guidance of radial artery puncture: A randomized study on a simulation model. J Clin Ultrasound. 2021 Mar;49(3):212-217. doi: 10.1002/jcu.22945. Epub 2020 Nov 16.
- Individual participant dataSharing planned: No
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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 study testing Needle-pilotTM device in people with Central Venous Catheters and Ultrasound Guidance, run by Centre Hospitalier Universitaire de Nīmes 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 1 inclusion and 1 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 4 Dec 2025. 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?
First puncture success delay (time frame: during the procedure). 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 NCT04463147, 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 4 Dec 2025.