TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
TES HT100 Clinical Outcomes - Clinical Validation of the TES HT100 Temnograph for Brain Injury Screening in Patients With Mild Head Trauma or Suspected Neurological Symptoms (TESCO)
- Mild Traumatic Brain Injury
- Intracranial Lesions
- Neurological Symptoms Not Related to Head Trauma
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- B&B srl
- Enrolment target
- 850
- Started
- 4 December 2024
- Main results due
- 30 December 2026
- Study sites
- 3
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(3)
Pineta Grande Hospital
Castel Volturno, CE, Italy
Recruiting
Emergency Department, University Clinical Centre, Medical University of Gdańsk
Gdansk, Poland
Not yet recruiting
Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice
Katowice, Poland
Recruiting
Showing 3 of 3 sites. 2 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07490418. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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