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An Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

NCT02704637 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-10-30

No results posted yet for this study

Summary

HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. The investigators hypothesize that the HS-1000 is capable of detecting vasospasm using the raw acoustic data derived from the noninvasive procedure.

Conditions

  • Vasospasm, Intracranial
  • Subarachnoid Hemorrhage

Interventions

DEVICE

HS-1000

HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians

Sponsors & Collaborators

  • University of Maryland, College Park

    collaborator OTHER

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • E. Francois Aldrich, MD · University of Maryland, College Park

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT02704637 on ClinicalTrials.gov