CoMind Early Feasibility Study
Public ClinicalTrials.gov record NCT06368648. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06368648
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 581 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2024
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
- Last update posted
- Sep 3, 2026
2024 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | Recruiting |
| Christiana Care | Wilmington | Delaware | 19899 | Completed |
| Medstar Health | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Jackson Memorial Hospital | Miami | Florida | 33136 | Recruiting |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | Recruiting |
| The University of Kansas Medical Center | Kansas City | Kansas | 66103 | Active, not recruiting |
| Washington University Medical Center | St Louis | Missouri | 63110 | Recruiting |
| Albany Medical College | Albany | New York | 12208 | Active, not recruiting |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | Recruiting |
| WakeMed | Raleigh | North Carolina | 27610 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | Active, not recruiting |
| University of Washington, Harborview | Seattle | Washington | 98104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06368648, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06368648 live on ClinicalTrials.gov.