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WITHDRAWN
NCT07550361
NA

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

Sponsor: Compremium AG

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2025-04-22

Completion Date

2026-04-30

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DEVICE

CPMX3 measurement

CPMX3 ICP measurement

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States