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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02773888
• Other study ID #: HS-018
• Status: Suspended
• Phase: N/A
• First received: May 12, 2016
• Last updated: February 23, 2017
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: HeadSense Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Neoplasms
• Hydrocephalus
• Intracranial Hypertension
• Stroke

Intervention

Device:
• HS-1000

Locations

Country	Name	City	State
Japan	Kuki General Hospital	Saitama
Japan	National Defense Medical College Hospital	Saitama
Japan	Juntendo University Shizuoka Hospital	Shizuoka
Japan	Nippon Medical School	Tokyo
Japan	Tokyo Jikei University Kashiwa Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
HeadSense Medical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ICP values obtained by the HS device that correlate to ICP using current standards		30 minutes
Secondary	Incidence of adverse events during and after recording sessions		96 hours