An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
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|ClinicalTrials.gov Identifier: NCT02773888|
Recruitment Status : Suspended (Recruitment temporarily held for site retraining)
First Posted : May 16, 2016
Last Update Posted : February 27, 2017
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hypertension Brain Injuries Stroke Hydrocephalus Brain Neoplasms||Device: HS-1000||Not Applicable|
A prospective study will be conducted on 80 patients with an inserted invasive intraparenchymal ICP monitor. Once a patient undergoes invasive ICP monitoring, has a life expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and has an intact/continuous dura layer, the patient will become a candidate for enrollment into the study. If the patient signs the informed consent or the patient's legal authorized representative signs on the patient's behalf, the patient will be enrolled into the trial. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's device. Once the data collection is complete, results will be analyzed by comparing ICP readings from both devices.
The primary end-point of the study is to collect 60-120 minutes of ICP monitoring data over two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. The secondary endpoint of this study is evaluate the safety of the device as measured by incidence of adverse events and serious adverse events over each subject's 96 hours of participation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: HS-1000 recording
ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.
- Number of ICP values obtained by the HS device that correlate to ICP using current standards [ Time Frame: 30 minutes ]
- Incidence of adverse events during and after recording sessions [ Time Frame: 96 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773888
|Kuki General Hospital|
|National Defense Medical College Hospital|
|Juntendo University Shizuoka Hospital|
|Nippon Medical School|
|Tokyo Jikei University Kashiwa Hospital|
|Principal Investigator:||Katsuji Shima||National Defense Medical College|