Clinical Trial

Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients

Study acronym: VENUS-ICPxP
Withdrawn
View on ClinicalTrials.gov →
Why the trial stopped
Operational decision not to proceed at this stage.
Summary
Intracranial pressure (ICP) monitoring is indicated in a wide range of neurological diseases. The combination of a linear ultrasound array with an integrated pressure sensor into a single handheld probe (ICP Probe) enables the user to precisely and non-invasively estimate blood pressure in a superficial vein overlying a hard structure. The periorbital vein located on the forehead above the eye is an interesting target since it is an emissary vein, directly connected through valveless vessels to the intracranial venous system. Its pressure might thus reflect intracranial pressure if it can be measured before being equalized by redistribution across the whole facial venous network. The usage of a pneumatic mask able to transiently occlude the site of measurement from the superficial venous network might therefore enable to correlate the venous occlusion pressure (VOP) of the periorbital vein to ICP. To confirm the hypothesis, the current clinical trial will compare measurements made with the CPMX3 system with invasively obtained ICP measures.
Trial Details
NCT Number NCT07550361
Lead Sponsor Compremium AG
Conditions Intracranial Pressure
Start Date 2025-04-22
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-24