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

NCT02773888 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-02-27

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

HS-1000

Sponsors & Collaborators

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • Katsuji Shima · National Defense Medical College

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773888 on ClinicalTrials.gov