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

NCT ID: NCT07222826

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-09-30

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 (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.

Conditions

Intracranial Pressure; Intracranial Pressure Changes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CPMX3 Measurement

CPMX 3 measurement

Group Type: EXPERIMENTAL

CPMX3

Intervention Type: DEVICE

CPMX3 periorbital vein pressure measurement

Interventions

CPMX3

CPMX3 periorbital vein pressure measurement

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Compremium AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Damon Judges

Role: CONTACT

d.judges@compremium.ch

+41775071995

Charlotte Moerman

Role: CONTACT

c.moerman@compremium.ch

Other Identifiers

NICE-ICP

Identifier Type: -

Identifier Source: org_study_id