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Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement

NCT02773901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-30

No results posted yet for this study

Summary

In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal

Conditions

  • Intracranial Hypertension

Interventions

DEVICE

HS-1000

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • Henrik Schytz, MD · Rigshospitalet-Glostrup

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Denmark
  • Germany
  • Netherlands

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 NCT02773901 on ClinicalTrials.gov