An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

Sponsor

HeadSense Medical (Industry)

Overall Status

Suspended

CT.gov ID

NCT02773888

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: HS-1000

Arm

Intervention/Treatment

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.

Device: HS-1000

Outcome Measures

Primary Outcome Measures

Number of ICP values obtained by the HS device that correlate to ICP using current standards [30 minutes]

Secondary Outcome Measures

Incidence of adverse events during and after recording sessions [96 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects, aged 14 years old and over at screening visit
Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology
Survival expectancy greater than 48 hours
Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

Subject with ear disease, ear trauma
Subject with a punctured or discontinuous dura layer (must be intact)
Subject with cerebral fluid (CSF) leakage
Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g. mental condition)

Contacts and Locations

Locations

	Site	City	Country
1	Kuki General Hospital	Saitama	Japan
2	National Defense Medical College Hospital	Saitama	Japan
3	Juntendo University Shizuoka Hospital	Shizuoka	Japan
4	Nippon Medical School	Tokyo	Japan
5	Tokyo Jikei University Kashiwa Hospital	Tokyo	Japan