Eye vein test could replace risky brain pressure monitoring
NCT ID NCT07222826
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called CPMX3 that measures pressure in a small vein near the eye to estimate pressure inside the skull. Currently, measuring brain pressure requires surgery to place a probe inside the head, which carries risks like infection and bleeding. The trial will enroll 15 people who already have an invasive monitor in place, comparing the new device's readings to the standard method to see if it is safe and accurate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CPMX3 device
- What this could lead to
- If successful, this could provide a safe, non-invasive way to measure pressure inside the skull, reducing the need for risky brain surgery.
- What could go wrong
- This is a very small, early safety and feasibility study with only 15 participants. The device may not prove accurate enough to replace current invasive methods.
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
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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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male or female * Age \> 18 * Equipped with an invasive ICP monitor as part of standard of care Exclusion Criteria: * Presence of facial and/or skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead * History of recent cranial surgery or hemicraniectomy * Active bleeding (proven or suspected) * History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.) * History, or known vein stenosis in ophthalmic veins/cavernous sinus * Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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