Actively Recruiting
CoMind Early Feasibility Study
Led by CoMind Technologies Limited · Updated on 2026-02-13
581
Participants Needed
14
Research Sites
100 weeks
Total Duration
On this page
Sponsors
C
CoMind Technologies Limited
Lead Sponsor
L
Lindus Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.
CONDITIONS
Official Title
CoMind Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female sex at birth, aged 18 years or older on the date of enrollment
- Receiving continuous invasive intracranial pressure monitoring (Bolt or EVD) as part of standard care
- Invasive ICP monitor catheter penetrating the parenchyma or ventricles
- Receiving continuous invasive arterial blood pressure monitoring as part of standard care
You will not qualify if you...
- Presence of any implant in the frontal bone near the CoMind One EFS Sensor that might touch it
- Open wounds on the forehead preventing safe placement of the CoMind One EFS Sensor over intact skin
- Radiographic evidence of a non-intact skull at the recording site on admission
- Enrollment in an intervention or study that could interfere with standard ICP measurements or CoMind device measurement
- Patients with decompressive craniectomy excluded unless intact skull area allows CoMind One EFS recording
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
Christiana Care
Wilmington, Delaware, United States, 19899
Active, Not Recruiting
3
Medstar Health
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
4
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Actively Recruiting
5
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Active, Not Recruiting
6
Washington University Medical Center
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Albany Medical College
Albany, New York, United States, 12208
Active, Not Recruiting
8
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Not Yet Recruiting
9
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
10
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
11
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Active, Not Recruiting
14
University of Washington, Harborview
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
D
David Diedo
CONTACT
B
Blake Butler
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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