Condition: Traumatic Brain Injury · Sponsor: Crainio Ltda
The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.
This description comes directly from the study's public registry record.
Jeremy Holland, Dr · 0779 626 5994 · Jeremy.Holland@crainio.com
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| Royal London Hospital | London, England, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06453733