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

Status: Recruiting
Location: See all (11) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UC Davis Medical Center
RECRUITING
Sacramento
Delaware
Christiana Care
RECRUITING
Wilmington
Florida
Jackson Memorial Hospital
RECRUITING
Miami
Kansas
The University of Kansas Medical Center
RECRUITING
Kansas City
Missouri
Washington University Medical Center
RECRUITING
St Louis
North Carolina
WakeMed
RECRUITING
Raleigh
New York
Albany Medical College
RECRUITING
Albany
Ohio
Ohio State University
RECRUITING
Columbus
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Virginia
Inova Fairfax Medical Campus
RECRUITING
Falls Church
Washington
University of Washington, Harborview
RECRUITING
Seattle
Contact Information
Primary
David Diedo
david@comind.io
305-290-1680
Backup
Rianna Mortimer
rianna@lindushealth.com
+447308 312168
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2026-11
Participants
Target number of participants: 581
Treatments
Patients receiving invasive ICP and ABP monitoring as their standard of care
Patients who are receiving invasive Intracranial Pressure (ICP) monitoring and invasive Arterial Blood Pressure (ABP) monitoring as per standard practice will serve as their own controls.
Related Therapeutic Areas
Sponsors
Leads: CoMind Technologies Limited
Collaborators: Lindus Health

This content was sourced from clinicaltrials.gov