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NCT Number: NCT07222826

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPMX3

Device

CPMX3 periorbital vein pressure measurement

Primary outcomes

  1. Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events

    Time frame: up to 7 days

  2. Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Device Deficiencies (DDs)

    Time frame: Up to 7 days

  3. Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Serious Adverse Device Effects (SADEs)

    Time frame: Up to 7 Days

  4. Preliminary accuracy of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, measured in mmHg

    Time frame: up to 7 days

    Preliminary accuracy will be assessed by recording paired measurements of venous occlusion pressure of the periorbital vein when isolated from its surrounding network and invasive ICP measurements from the standard of care invasive ICP monitor in mmHg

Secondary outcomes

  1. Feasibility of finding and compressing the target periorbital vein as reported by the investigator using a visual analog scale 0 to 3

    Time frame: up to 7 days

    As reported by investigator using a visual analog scale score from 0 to 3 (0: not able to visualize the vein, 3: perfectly able to visualize)

  2. The tolerability of the non-invasive measurement process, evaluated via a dedicated patient questionnaire on patient comfort

    Time frame: up to 7 days

    Evaluated by each participant before study termination through a dedicated questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Moerman

CONTACT

[email protected]

Damon Judges

CONTACT

[email protected]

+41775071995

Sponsors and collaborators

Lead sponsor

Compremium AG

Industry

Registry information

Official study title

Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein (NICE-ICP)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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