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New tech aims to make emergency brain drains safer and more accurate

NCT ID NCT03696043

Knowledge-focused Sponsor: University of Wisconsin, Madison 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether using a special image-guidance system (AxiEM Stealth) helps doctors place a brain drain more accurately at the bedside compared to the usual freehand method. The drain is needed to relieve pressure in the brain. The study included 31 adults who needed this procedure. The goal was to see if the technology reduces the number of attempts and improves placement accuracy.

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

31 people

The number who actually took part.

Started

Aug 2018

Finished

Mar 2026

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 88 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 undergoing bedside external ventricular drain placement determined by attending physician * Age ≥ 18 years and ≤ 88 years * Male or Female * Patients or consentable family member must sign a written informed consent prior to EVD placement * Stealth compatible head CT or MRI Exclusion Criteria: * Patients ≤ 18 and ≥ 88 years of age * Prisoner status * Subjects who decline participation into the study * Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician * Patients who undergo emergent EVD placement via emergency consent * Subjects for whom self-consent or consent by a LAR cannot be obtained or cannot be obtained * Pregnant women * Non-English speaking patients

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Conditions

The condition(s) this trial relates to.

intracranial hypertension

As listed by the trial registrant

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

External ventricular drain Intracranial pressure

Contacts and locations

Locations

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.