Status:
RECRUITING
Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein
Lead Sponsor:
Compremium AG
Conditions:
Intracranial Pressure
Intracranial Pressure Changes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Elevated intracranial pressure is a common complication of brain injury which means that the pressure within the skull rises above normal levels. The negative impact of increased intracranial pressure...
Eligibility Criteria
Inclusion
- Male or female
- Age \> 18
- Equipped with an invasive ICP monitor as part of standard of care
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07222826
Start Date
September 30 2025
End Date
September 30 2026
Last Update
October 30 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030