Condition: Mild Traumatic Brain Injury · Intracranial Lesions · Neurological Symptoms Not Related to Head Trauma · Sponsor: B&B srl
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
This description comes directly from the study's public registry record.
Fabrizio Alfieri · +39-081-19189806 · fabrizio.alfieri@temnography.com
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| Pineta Grande Hospital | Castel Volturno, CE, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07490418