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TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms

RecruitingNAAges 18 Years - anyAllB&B srl
NCT07490418 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are not related to trauma and are not immediately life-threatening. The main questions it aims to answer are: * How well does TES HT100 identify patients with intracranial abnormalities compared with head CT, the reference standard? * Is TES HT100 safe to use in this patient population? * Could TES HT100 help improve patient triage and use of hospital resources in the emergency setting? Researchers will compare the result of TES HT100 with the head CT report. Participants will: * Be enrolled if they are adults presenting to the emergency department with mild head trauma or selected neurological symptoms * Undergo standard clinical assessment and head CT according

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age greater than 18 years * Provision of informed consent * Presentation to the Emergency Department with mild head injury, or * Presentation to the Emergency Department for non-traumatic neurological symptoms and not in a critical condition, including: * syncope * spatial disorientation and/or loss of balance * speech disturbance and/or facial hemi-paresis * visual alterations * memory loss and/or confusional state Exclusion Criteria: * Age less than 18 years * Pregnant women * Metal plates or metal prostheses installed in the skull cap * Severe head trauma and/or extensive lacerated-contused areas * Critical condition * Visible skull fracture * Failure or inability to provide signed informed consent
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What it tests

  • Temnographic Brain Screening Examination
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Where

3 sites
Pineta Grande Hospital
Castel Volturno, Italy
Emergency Department, University Clinical Centre, Medical University of Gdaล„sk
Gdansk, Poland
Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice
Katowice, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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