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New device aims to make ICU catheter insertion faster and safer

NCT ID NCT06050902

Symptom relief Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a new needle-steering device that helps doctors place central lines (large IVs) in ICU patients. The device uses special software and a magnetized needle to guide placement more accurately than standard ultrasound. Researchers will compare success rates and complications in 124 patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
needle-steering device
What this could lead to
If it works, this device could make inserting central lines quicker and less painful for ICU patients, reducing complications.
What could go wrong
This is a small, early-stage trial on a mannequin, so results may not translate to real patients. The device may not improve success rates in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

124 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Any resuscitation patient requiring subclavian venous catheterization. * Patients or representatives must have given free, informed consent and signed the consent form or patient included in an emergency situation * Patients must be affiliated to/or beneficiary of a health insurance scheme. * All patients must be adults (≥18 years of age). Exclusion Criteria: * Moribund patients * Patients with severe primary or secondary hemostasis disorders (Pq \< 50 G/L or TP \< 30%, or INR \> 2). * Patients with a PaO2/FiO2 ratio \< 100 mmHg in mechanically ventilated patients (invasive or non-invasive ventilation). * Patients with a precarious or unstable respiratory status and significant risk of barotrauma * Patients for whom it is difficult to visualize the subclavian veins bilaterally (left and right) during ultrasound pre-screening * Patients with a malformation/deformity of the subclavian region (congenital or acquired: history of surgery/cervical trauma) * Body mass index \< 15 kg/m² ou \> 40 kg/m² * Local infection at the puncture site * Thrombosis of the subclavian or axillary vein * Patients participating in a category 1 defined RIPH involving subclavian central venous line placement. * Patients under court protection, guardianship or curatorship. * Pregnant, parturient or breastfeeding women.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central venous catheterization Ultrasound guidance

Contacts and locations

Locations

  • CHU de NIMES

    Nîmes, 30029, France

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