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Brain monitor showdown: awake patient vs. High-Tech headband

NCT ID NCT07485933

Knowledge-focused Sponsor: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two methods to detect reduced blood flow to the brain during carotid artery surgery: asking awake patients to move their hand versus using a near-infrared spectroscopy (NIRS) headband. The trial involves 160 people with narrowed carotid arteries. The goal is to see if the NIRS device works as well as the standard awake testing to guide the use of a temporary bypass tube.

What this could mean

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

What this could lead to
If NIRS proves equivalent to awake testing, it could offer a simpler, continuous way to monitor brain blood flow during carotid surgery, potentially reducing stroke risk.
What could go wrong
This is a single-center study with 160 participants, so results may not apply broadly. NIRS might miss some cases of brain ischemia that awake testing catches.

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

160 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 with asymptomatic and symptomatic narrowing of the carotid artery in whom operative treatment is indicated, diagnosed by initial Duplex ultrasonographic examination or CT angiography. * Written consent of the patient to participate in the study Exclusion Criteria: * \- previous hemorrhagic stroke * non-atherosclerotic carotid disease * significant atherosclerotic changes in the aortic arch * hypercoagulable and conditions with embologenic potential (congenital or acquired thrombophilia, malignant disease, atrial fibrillation, significant heart failure and valvular disease)

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Conditions

The condition(s) this trial relates to.

carotid artery disorder carotid stenosis

As listed by the trial registrant

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

Carotid arteriosclerosis Near-infrared spectroscopy

Contacts and locations

Locations

  • Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

    Belgrade, 11000, Serbia

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