NCT06453733 Crainio Non-invasive ICP Monitor for TBI
| NCT ID | NCT06453733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Crainio Ltda |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-05-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of traumatic brain injury. * Adults (aged between 16 and 99, male and female) * TBI patients admitted to the Royal London Hospital. * Patients having invasive ICP monitoring as part of their normal medical treatment. Exclusion Criteria: * Forehead skin is not intact. * Decompressive craniectomy patients. * Open external ventricular drainage (EVD) treatment. * Patients who will unlikely survive the following twelve hours.
Contact & Investigator
Chris Uff, Dr
PRINCIPAL INVESTIGATOR
Barts & The London NHS Trust
Frequently Asked Questions
Who can join the NCT06453733 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 99 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453733 currently recruiting?
Yes, NCT06453733 is actively recruiting participants. Contact the research team at Jeremy.Holland@crainio.com for enrollment information.
Where is the NCT06453733 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06453733 clinical trial?
NCT06453733 is sponsored by Crainio Ltda. The principal investigator is Chris Uff, Dr at Barts & The London NHS Trust. The trial plans to enroll 54 participants.