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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities — At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT
  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.
• Rate of device-related adverse events — From TES HT100 examination through study participation completion, an average of 1 year
  Incidence and type of adverse events related to the use of TES HT100 during the study.

Trial sites (3)