CPMX3 for Intracranial Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a device called CPMX3, which measures pressure in a vein near the eye to help track intracranial pressure (pressure inside the skull). High intracranial pressure can be dangerous, especially after a brain injury, and is usually measured with invasive procedures that carry risks. The CPMX3 provides a non-invasive way to measure this pressure, potentially avoiding complications of current methods. The trial seeks participants who already have an invasive ICP monitor as part of their standard care. As an unphased trial, this study allows participants to contribute to innovative research that could lead to safer, non-invasive monitoring methods.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What prior data suggests that the CPMX3 system is safe for non-invasive intracranial pressure measurement?
Research has shown that the CPMX3 system safely and simply checks pressure inside the skull by using a vein near the eye. This method avoids the risks of more invasive techniques, such as infections and bleeding. Studies have not identified any major side effects with the CPMX3 device, indicating that it is well-tolerated and safe for monitoring intracranial pressure.12345
Why are researchers excited about this trial?
Unlike the standard treatments for intracranial hypertension, such as diuretics or surgical interventions, CPMX3 offers a novel approach with its unique mechanism of action. Researchers are excited about CPMX3 because it targets the condition differently, potentially reducing intracranial pressure more effectively and with fewer side effects. This new method could provide a much-needed alternative for patients who don't respond well to current options, promising quicker relief and improved quality of life.
What evidence suggests that the CPMX3 system is effective for measuring intracranial pressure?
Research has shown that high pressure inside the skull, known as increased intracranial pressure (ICP), can lead to poor outcomes for people with brain injuries. Monitoring ICP is crucial because it reduces the risk of death. Current methods, however, are invasive and can cause issues like infections and bleeding. In this trial, participants will use the CPMX3 system, a new, non-invasive method to check ICP by examining a vein near the eye. While past non-invasive methods have not been very effective, this new approach might offer safer, long-term monitoring. Although specific data on CPMX3's effectiveness is not yet available, it appears promising as it avoids the complications of invasive procedures.36789
Are You a Good Fit for This Trial?
This trial is for individuals experiencing headaches and intracranial hypertension, which means they have higher than normal pressure inside their skull. Participants should be those who may benefit from non-invasive monitoring of this pressure to avoid the risks associated with traditional invasive methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo non-invasive ICP measurement using the CPMX3 system
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CPMX3
Find a Clinic Near You
Who Is Running the Clinical Trial?
Compremium AG
Lead Sponsor