Needle-Free brain pressure test for kids hits snag before starting
NCT ID NCT07550361
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to see if a handheld device called CPMX3 could safely estimate brain pressure in children by measuring pressure in a forehead vein. It planned to compare these readings with standard invasive measurements in children aged 8 to 21 who already had brain pressure monitors. However, the study was withdrawn before any participants were enrolled, so no conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CPMX3 measurement device
- What this could lead to
- If it had worked, this could have led to a safer, non-invasive way to measure brain pressure in children, avoiding the need for surgery.
- What could go wrong
- The study was withdrawn before enrolling anyone, so no data was collected. Even if it had proceeded, it was a small feasibility study, so results would have been very preliminary.
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.
- Expected to start
-
Apr 2025
An estimate. Start dates often move.
- Expected to finish
-
Apr 2026
An estimate. End dates often move.
- Lead sponsor
-
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
-
8 to 21 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required 2. Male or female 3. Age: 8 to 21 years of age 4. Equipped with an ICP monitor (intraparenchymal probe or EVD) as part of standard of care Exclusion Criteria: 1. Presence of facial trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead 2. Presence of fractures of the skull 3. 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.
Contacts and locations
Locations
-
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
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Other studies related to the condition(s) this trial covers.
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