An interventional study of Temnographic Brain Screening Examination in Mild Traumatic Brain Injury, Intracranial Lesions and Neurological Symptoms Not Related to Head Trauma, sponsored by B&B srl. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by B&B srl · Not applicable, Interventional, and Diagnostic
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:
Researchers will compare the result of TES HT100 with the head CT report.
Participants will:
This is a prospective, multicenter, open-label clinical investigation evaluating the TES HT100 as a non-invasive adjunctive screening device for detection of intracranial abnormalities in adult Emergency Department patients. The study is being conducted in three centers in Italy and Poland.
TES HT100 is intended for non-invasive detection of endocerebral lesions. The device used in this investigation is TES HT model 100, equipped with software version 1.3 or later and firmware version 1.4 or later, in the same configuration planned for commercialization. The system uses non-ionizing, ultra-low-power electromagnetic waves in the 500-6500 MHz frequency range and provides a binary result indicating the presence or absence of intracranial abnormality. The examination is brief, with an overall duration of about 5 minutes.
The study is designed to evaluate the diagnostic performance and safety of TES HT100 when used in addition to standard emergency care. Participants undergo routine clinical assessment and brain CT according to usual clinical practice, and the TES HT100 examination is performed as an add-on procedure. The reference standard for performance evaluation is the brain CT report. TES HT100 is not intended to replace standard clinical assessment or CT imaging.
To reduce interpretation bias, the TES HT100 examination is performed by trained personnel who do not have access to the CT report at the time of testing, and the radiologist interpreting the CT scan is blinded to the TES HT100 result. TES HT100 examinations are performed within 24 hours before or after CT, according to site workflow.
The investigation plans to enroll approximately 850 participants overall across two clinical cohorts. The study duration is planned to be 30 months. Three TES HT100 devices, one per participating center, will be used under the same qualification and maintenance procedures.
In addition to diagnostic validation against CT, the study includes safety monitoring during device use and an exploratory assessment of the potential clinical utility of TES HT100 in emergency department triage and resource management. The overall objective is to generate clinical evidence on the performance and safety of TES HT100 as a rapid, non-invasive screening support tool in the emergency setting.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 850 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants receive standard emergency department evaluation, including head CT according to usual clinical practice, and undergo an additional TES HT100 examination as an add-on procedure. TES HT100 is evaluated against the head CT report used as the reference standard. The study includes adults with mild head injury and adults with neurological symptoms not related to head trauma and not in a critical or life-threatening condition.
Diagnostic Test: Temnographic Brain Screening Examination
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.
Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
Diagnostic performance of TES HT100 compared with the head CT report as the reference standard, assessed by ROC-AUC and by sensitivity and specificity for identification of intracranial abnormalities.
Time frame: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT
Rate of device-related adverse events
Incidence and type of adverse events related to the use of TES HT100 during the study.
Time frame: From TES HT100 examination through study participation completion, an average of 1 year
Operator time associated with TES HT100-supported screening
Descriptive evaluation of operator time associated with use of TES HT100 during emergency department screening, based on the number of TES HT100 examinations performed per participant and the approximate duration of each examination (about 5 minutes), as described in the protocol.
Time frame: Day 1
Procedures associated with TES HT100-supported screening
Descriptive evaluation of workflow-related procedures associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol. This may include patient handling or organizational procedures required during the diagnostic pathway, such as patient transfer to a different bed or room or need for additional staff support.
Time frame: Day 1
Costs associated with TES HT100-supported screening
Descriptive evaluation of resource use and related cost considerations associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol.
Time frame: Day 1
Diagnostic performance of TES HT100 in predefined patient subgroups
Analysis of TES HT100 diagnostic performance, based on sensitivity and specificity versus head CT, in predefined subgroups, including younger patients, older patients, patients with or without prior injury or brain surgery, and patients with or without neurodegenerative disease.
Time frame: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — De-identified participant-level data may be shared upon reasonable request, subject to ethics and institutional approval where applicable and execution of a data sharing agreement. Public sharing is not planned due to confidentiality and consent restrictions.
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