Intracranial PressureVENUS-ICPxPNCT07550361
Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients
A study testing CPMX3 measurement in people with Intracranial Pressure, run by Compremium AG at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- CPMX3 measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
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
- Being tested
- CPMX3 measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMX3 measurementDevice
CPMX3 ICP measurement
| Study group | Role | What they receive |
|---|---|---|
| CPMX3 measurement | Experimental | Not described Receives: Device: CPMX3 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start22 Apr 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Why it stopped: Operational decision not to proceed at this stage.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compremium AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550361
- Sponsor's protocol ID
- STUDY00001177
- Acronym
- VENUS-ICPxP
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07550361
- Acronym / sponsor ID
- VENUS-ICPxP / STUDY00001177
- Conditions
- Intracranial Pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Operational decision not to proceed at this stage.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Compremium AGIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPMX3 measurement | Experimental | Device: CPMX3 measurement |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPMX3 measurementCPMX3 ICP measurement | Device | CPMX3 measurement |
Primary outcome
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
- 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPMX3 measurement in people with Intracranial Pressure, run by Compremium AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.