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Study identifier: NCT07490418 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Mild Traumatic Brain Injury · Intracranial Lesions · Neurological Symptoms Not Related to Head Trauma  ·  Sponsor: B&B srl

PhaseNA
Planned participants850
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

Talk to the study team

Fabrizio Alfieri  ·  +39-081-19189806  ·  fabrizio.alfieri@temnography.com

Always discuss trial participation with your own doctor first.

Locations (1)

Pineta Grande HospitalCastel Volturno, CE, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07490418