Validation of TES HT100 Device for Detecting Brain Injuries in Adults with Mild Head Trauma or Neurological Symptoms in Emergency Departments

What this Trial Is About

Researchers are evaluating the TES HT100 device to see how accurately and safely it can detect intracranial abnormalities in adult patients who come to the emergency department with mild head trauma or neurological symptoms that are not related to trauma and are not immediately life-threatening. The study aims to understand how well TES HT100 compares to head CT, the standard method, and whether it can help improve patient triage and hospital resource use. Participants will receive the standard emergency department evaluation including a head CT scan as usual care. In addition, they will undergo a TES HT100 examination, which is a non-invasive test that uses ultra-low-power electromagnetic waves and takes about 5 minutes. This TES HT100 test is performed by trained personnel and provides a simple yesno result about the presence of brain abnormalities. The study is conducted at multiple centers using three TES HT100 devices over about 30 months, with the TES HT100 test done within 24 hours before or after the CT scan. During the study, participants will have routine clinical assessments, head CT scans, and the TES HT100 test. Researchers will compare TES HT100 results to CT reports to evaluate diagnostic accuracy and monitor any adverse events from TES HT100 use over an average of one year. They will also study how TES HT100 impacts screening time, procedures, and costs. The research aims to provide evidence on TES HT100s performance and safety as a quick, non-invasive screening tool in emergency care.

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