Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
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|ClinicalTrials.gov Identifier: NCT02772471|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.
HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries Intracranial Hypertension||Device: HS-1000||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: HS-1000 recording
ICP monitoring will be done in parallel for both HS-1000 and invasive ICP monitoring. HS-1000 ICP monitoring intervals will last at least 30 minutes, continuously depending on the patient's clinical condition.
- Number of ICP values obtained by the HS device that correlate to ICP using current standards [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772471
|Oslo University Hospital|
|Principal Investigator:||Per Kristian Eide, MD, PhD||Oslo University Hospital|