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Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM to Transcranial Doppler as an Aid to Diagnosing Vasospasm

NCT01595802 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2022-06-09

No results posted yet for this study

Summary

The purpose of the study is to determine the sensitivity, specificity and predictive values of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison to Trans Cranial Doppler(TCD).

Conditions

  • Cerebral Vasospasm

Interventions

DEVICE

Nautilus NeuroWave

The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made. In this intervention, patients are recorded using the Nautilus Neurowave device.

DEVICE

Transcranial Doppler (TCD)

Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.

Sponsors & Collaborators

  • Jan Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Wade Smith, M.D, PH.D. · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-07-31
Completion
2015-07-31

Countries

  • United States

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 NCT01595802 on ClinicalTrials.gov