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Can a simple marking device make epidurals safer and faster?

NCT ID NCT04985279

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial evaluates a new device called PAMS that attaches to an ultrasound probe to mark the exact spot for epidural needle insertion and measure the correct angle. The study involves healthy volunteers acting as patients and anesthesia doctors as operators, who will practice on a mannequin and then perform simulated procedures on the volunteers. The goal is to see if PAMS is easier to use and more accurate than the current method of marking with pens, which can be washed off by skin sterilization. Feedback from both doctors and volunteers will help refine the device for future use.

What this could mean

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

Active substance
Position and Angle Marking System (PAMS) – a device that attaches to an ultrasound probe to mark the needle insertion point and measure the angle for epidural placement.
What this could lead to
If PAMS works well, it could make epidural placement faster and more accurate, improving pain relief during labor and reducing complications.
What could go wrong
This is an early usability study with a small number of participants, so it may not prove that PAMS is better in real clinical settings. The device may also need design improvements based on feedback.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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

Accepted

You do not need to have the condition being studied to take part.

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.

Ultrasound operators Inclusion Criteria: * Anaesthesiologists * Trained in the use of ultrasound-guided neuraxial procedures Exclusion Criteria: * No experience with ultrasound-guided neuraxial procedures Simulated patients Inclusion Criteria: * Healthy, no significant medical comorbidity (American Society of Anesthesiologists Physical Status I or II) * No spinal abnormalities, or previous spinal surgery Exclusion Criteria: * Significant spinal abnormality * Previous spinal surgery

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As listed by the trial registrant

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

Contacts and locations

Locations

  • KK Women's and Children's Hospital

    Singapore, 128038, Singapore