UnknownNot Applicable

An Evaluation of a Non-invasive Brain Monitor

Germany160 participantsStarted 2014-10

Plain-language summary

HS-1000 device, a proprietary new 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. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult men and women subjects, aged 18 years old and over at screening visit
✓. Subjects with neuropathology that the principal investigator considers including in this study.
✓. Survival expectancy greater than 72 hours
✓. Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
✓. Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion criteria

✕. Local ear infection
✕. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
✕. For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
✕. Subarachnoid hemorrhage (SAH), Fisher Grade 4
✕. Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
✕. Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)

What they're measuring

Number of recordings that correlate to neuropathology

Timeframe: up to 1 hour

Trial details

NCT IDNCT02775136

SponsorHeadSense Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

Contact for this trial

Thomas Swanson

thomas@head-sense-med.com

View on ClinicalTrials.gov More Brain Injuries trials