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Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein

Compremium AG · NCT07222826

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
15
US sites recruiting
1
Study start
September 30, 2025
Record last updated
October 30, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 (ICP) on the prognosis of patients has been strongly shown in numerous studies and ICP-based treatment is associated with an important reduction of risk of death. Invasive ICP measurement methods are nowadays a standard of care in severe brain injury. The two available ways of measuring ICP require neurosurgical procedure to implant a catheter and probes within the brain and present risks and complications for the patient, such as infections and intracranial bleeding. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities, limiting the application of ICP measurements to patients of the acute neuro-ICU (neuro-Intensive Care Unit) with acute brain damage requiring close surveillance to prevent further deterioration of neural tissue and disability. Non-invasive ICP monitoring benefits include no risk of complications seen in invasive monitoring, helping in deciding which patient needs invasive ICP monitoring, and providing ongoing long-term measurements of ICP without having to insert a new device every time. Although many non-invasive ICP measurement methods have been explored, to date, none of them have shown clinical success or usefulness. One under-explored window to ICP is the orbital vein, a small blood vessel located near your eye, which we think could provide a direct link to the intracranial pressure. The study device, called the CPMX3 system, is a non-invasive method to measure pressure in a superficial periorbital vein.

Being studied: CPMX3

Conditions: Intracranial Pressure; Intracranial Pressure Changes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Damon Judges · +41775071995 · d.judges@compremium.ch
  • Charlotte Moerman · c.moerman@compremium.ch
Non-invasive Intracranial Pressure Estimation by Measurement of… (NCT07222826) | Bored Studies