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

NCT07550361 | Withdrawn FDA Device

• 1 other identifier: STUDY00001177
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Pressure

Outcome Measures

Primary Outcomes (1)

• Safety of venous occlusion pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP in pediatric patients.

  \- Safety of the device shall be evaluated by systematically reporting Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device.

  Up to 7 days

Other Outcomes (1)

• Preliminary accuracy of CPMX3 measurement of ICP via the occlusive pressure measuremnet of the supraorbital vein

  Up to 7 days

Study Arms (1)

CPMX3 measurement

EXPERIMENTAL

Device: CPMX3 measurement

Interventions

CPMX3 measurement DEVICE

CPMX3 ICP measurement

CPMX3 measurement

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required
• Male or female
• Age: 8 to 21 years of age
• Equipped with an ICP monitor (intraparenchymal probe or EVD) as part of standard of care

You may not qualify if:

• Presence of facial trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead
• Presence of fractures of the skull
• Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.

Sponsors & Collaborators

• Compremium AG: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator performing the pressure measurement with CPMX3 will be blinded from the invasive intracranial pressure value for the duration of measurement with CPMX3
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 24, 2026
• Study Start: April 22, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)