Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients
NCT02695264 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2016-12-23
Summary
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external ventricular device (EVD) or parenchymal (bolt) monitoring devices in the pediatric population.
Conditions
- Intracranial Hypertension
Interventions
- DEVICE
-
HS-1000 recording
Sponsors & Collaborators
-
Akron Children's Hospital
collaborator OTHER -
HeadSense Medical
lead INDUSTRY
Principal Investigators
-
Michael L Forbes, MD · Akron Children's Hospital
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
Countries
- United States
Study Locations
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