Status:
UNKNOWN
Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
Lead Sponsor:
Boston Neurosciences
Conditions:
Intracranial Hypertension
Abnormality of Intracranial Pressure
Eligibility:
All Genders
18-80 years
Brief Summary
For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values o...
Detailed Description
This study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (ICP) device based on trans-cranial Doppler...
Eligibility Criteria
Inclusion
- ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation.
Exclusion
- History of:
- Glaucoma or optic hypertension
- Severe orbital or ophthalmic injury
- Orbital or intraocular surgery that might interfere with orbital compliance
- Congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03865576
Start Date
March 1 2019
End Date
October 31 2019
Last Update
March 7 2019
Active Locations (4)
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1
Honor Health Research Institute
Phoenix, Arizona, United States, 85258
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
4
University of Washington
Seattle, Washington, United States, 98195