TES HT100 screening for intracranial problems after mild head injury or new neurological symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open‑label investigation in adult emergency department patients comparing a brief TES HT100 examination with routine head CT. The TES HT100 uses ultra‑low‑power electromagnetic waves (500–6500 MHz) to produce a binary result indicating presence or absence of intracranial abnormality, and the exam takes about five minutes. Trained staff perform the TES HT100 without access to the CT report, and radiologists reading the CT are blinded to TES results; CT reports serve as the reference standard. The device is tested as an add‑on to usual care and is not intended to replace clinical assessment or CT imaging.

Why it matters

Who can join: the full rules

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

Where it's running

• Pineta Grande Hospital
  Castel Volturno, Ce, Italy Recruiting
• Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice
  Katowice, Poland Recruiting
• Emergency Department, University Clinical Centre, Medical University of Gdańsk
  Gdansk, Poland Not yet recruiting

Study contacts

• Study coordinator: Fabrizio Alfieri
• Email: fabrizio.alfieri@temnography.com
• Phone: +39-081-19189806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.