Status:
RECRUITING
CoMind Early Feasibility Study
Lead Sponsor:
CoMind Technologies Limited
Collaborating Sponsors:
Lindus Health
Conditions:
Intracranial Pressure
Intracranial Pressure Changes
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) t...
Detailed Description
A prospective, observational study, determined as non-significant risk by the Central IRB, to assess and improve performance of a non-invasive ICP estimation system. The development of non-invasive sy...
Eligibility Criteria
Inclusion Criteria:
- Male or female sex at birth, and aged 18 years or older on the date of enrollment.
- Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.
- Invasive ICP monitor catheter penetrating the parenchyma or ventricles.
- Receiving continuous invasive ABP monitoring as part of standard care.
Exclusion Criteria:
- 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.
- Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin
- Presenting with radiographic evidence of a non-intact skull at the recording site on admission.
- 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.
- Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.
Key Trial Info
Start Date :
November 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT06368648
Start Date
November 27 2024
End Date
November 1 2026
Last Update
February 13 2026
Active Locations (14)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817
2
Christiana Care
Wilmington, Delaware, United States, 19899
3
Medstar Health
Washington D.C., District of Columbia, United States, 20010
4
Jackson Memorial Hospital
Miami, Florida, United States, 33136