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New device aims to reduce needle sticks during central line placement

NCT ID NCT05513378

Knowledge-focused Sponsor: Thomas Kander 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a needle guide during ultrasound-guided subclavian vein catheterization reduces the number of skin punctures. 300 adults in Sweden were randomly assigned to have the procedure with or without the guide. The goal is to see if the guide makes the process safer and faster.

What this could mean

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

Active substance
Ultra-Pro II™ Needle Guide (device)
What this could lead to
If successful, this could make central line placement safer and more efficient by reducing needle sticks and complications.
What could go wrong
This is a completed, moderate-sized trial, but the needle guide may not improve outcomes or could be cumbersome for operators.

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

300 people

The number who actually took part.

Started

Nov 2022

Finished

Sep 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 to 105 years

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: * Patients in need of a central venous catheter . * Clinical indication for the subclavian route which includes expected time of use \>5 days. * Signed informed consent. Exclusion Criteria: * Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).

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As listed by the trial registrant

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

Catheterization, central venous Complications; catheter, mechanical

Contacts and locations

Locations

  • Intensive and Perioperative Care. Skåne University Hospital. Lund

    Lund, Skåne County, 22185, Sweden

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