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Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

NCT02772471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-13

No results posted yet for this study

Summary

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.

HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

Conditions

  • Brain Injuries
  • Intracranial Hypertension

Interventions

DEVICE

HS-1000

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • Per Kristian Eide, MD, PhD · Oslo University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Norway

Study Locations

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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 NCT02772471 on ClinicalTrials.gov