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

Primary Purpose

Intracranial Hypertension, Brain Injuries, Stroke

Status
Suspended
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
HS-1000
Sponsored by
HeadSense Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Hypertension focused on measuring intracranial pressure, noninvasive monitoring

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Kuki General Hospital
  • National Defense Medical College Hospital
  • Juntendo University Shizuoka Hospital
  • Nippon Medical School
  • Tokyo Jikei University Kashiwa Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HS-1000 recording

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of ICP values obtained by the HS device that correlate to ICP using current standards

Secondary Outcome Measures

Incidence of adverse events during and after recording sessions

Full Information

First Posted
May 12, 2016
Last Updated
February 23, 2017
Sponsor
HeadSense Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02773888
Brief Title
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Official Title
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Suspended
Why Stopped
Recruitment temporarily held for site retraining
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeadSense Medical

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension, Brain Injuries, Stroke, Hydrocephalus, Brain Neoplasms
Keywords
intracranial pressure, noninvasive monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HS-1000 recording
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HS-1000
Primary Outcome Measure Information:
Title
Number of ICP values obtained by the HS device that correlate to ICP using current standards
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Incidence of adverse events during and after recording sessions
Time Frame
96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuji Shima
Organizational Affiliation
National Defense Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuki General Hospital
City
Saitama
Country
Japan
Facility Name
National Defense Medical College Hospital
City
Saitama
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Shizuoka
Country
Japan
Facility Name
Nippon Medical School
City
Tokyo
Country
Japan
Facility Name
Tokyo Jikei University Kashiwa Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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