CoMind Early Feasibility Study

Launched by COMIND TECHNOLOGIES LIMITED · Apr 11, 2024

Keywords

ClinConnect Summary

The CoMind Early Feasibility Study is looking into a new way to measure pressure around the brain, known as intracranial pressure (ICP), without needing to perform surgery. Currently, measuring ICP requires drilling a hole in the skull, which can lead to complications like infections and pain. This study aims to gather information to help develop a safer, non-surgical device that can monitor ICP effectively. Researchers will collect data from patients who are already receiving standard surgical ICP monitoring to help test and improve this new technology.

To participate in this trial, individuals must be at least 18 years old and currently undergoing continuous invasive ICP monitoring as part of their medical treatment. The study is open to all genders. Participants will have both the standard surgical device and the new research device applied to their head, allowing researchers to compare the two methods. This study not only aims to improve patient care for conditions like traumatic brain injury and stroke but also hopes to offer a more comfortable and safer way to monitor brain pressure in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.
• • 2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
• • 3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
• • 4. Receiving continuous invasive ABP monitoring as part of standard care.
• Exclusion Criteria:
• • 1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.
• • 2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
• • 3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
• • 4. If patient is enrolled in an intervention/study that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.
• • 5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.