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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Page 1 of 1 (4 locations)

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