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TrialNCT06368648

CoMind Early Feasibility Study

Status
RECRUITING
Phase
Not listed
Last update posted
09/04/2026
Start
11/27/2024
Sponsor
CoMind Technologies Limited
Specialties
emergency, cardiology

Conditions: Intracranial Pressure; Intracranial Pressure Changes; Traumatic Brain Injury; Intracerebral Hemorrhage; Encephalitis; Encephalopathy; Hydrocephalus; Stroke; Autoregulation

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) 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.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

Clinical Evidence