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

Sponsor: B&B srl • ClinicalTrials.gov ID: NCT07490418

Registry updated: 2026-09-24

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Description

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 to usual care * Have an additional TES HT100 examination lasting about 5 minutes, performed by trained personnel * Be assessed for device performance and any adverse events related to use of the device

Interventions

Temnographic Brain Screening Examination (Diagnostic test)
A non-invasive, add-on diagnostic examination performed with the TES HT100 device to assess the presence or absence of intracranial abnormality in adult emergency department patients. The device uses ultra-low-power, non-ionizing electromagnetic waves in the 500-6500 MHz range and provides a binary on/off result. The examination lasts about 5 minutes, does not require direct contact with the patient's head, and is performed by trained personnel in addition to standard clinical evaluation and head CT.

Eligibility criteria

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

Conditions

Mild Traumatic Brain Injury Intracranial Lesions Neurological Symptoms Not Related to Head Trauma

Locations

Pineta Grande Hospital — Castel Volturno, CE, Italy
Emergency Department, University Clinical Centre, Medical University of Gdańsk — Gdansk, Poland
Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice — Katowice, Poland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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