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Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device

NCT03865576 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-03-07

No results posted yet for this study

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 obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.

Conditions

  • Intracranial Hypertension
  • Abnormality of Intracranial Pressure

Interventions

DIAGNOSTIC_TEST

Non-invasive ICP measurement

Intracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors

Sponsors & Collaborators

  • Boston Neurosciences

    lead INDUSTRY

Principal Investigators

  • T Forcht Dagi, MD, DMedSc · Boston Neurosciences

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-31
Completion
2019-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865576 on ClinicalTrials.gov