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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Compremium AG
Study ID
NCT07550361
Status
Withdrawn

Conditions

  • Intracranial Pressure

Eligibility Criteria

Sex
ALL
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • CPMX3 measurement — DEVICE
    CPMX3 ICP measurement

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CPMX3 measurement

Primary Outcome Measure

Safety of venous occlusion pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP in pediatric patients. [ Time Frame: Up to 7 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-

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Children's National Hospital· Washington D.C., DC

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