Actively Recruiting
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
Led by B&B srl · Updated on 2026-03-24
850
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Provision of informed consent
- Presentation to the Emergency Department with mild head injury, or
- Presentation to the Emergency Department for non-traumatic neurological symptoms and not in a critical condition, including syncope, spatial disorientation and/or loss of balance, speech disturbance and/or facial hemi-paresis, visual alterations, memory loss and/or confusional state
You will not qualify if you...
- Age less than 18 years
- Pregnant women
- Metal plates or metal prostheses installed in the skull cap
- Severe head trauma and/or extensive lacerated-contused areas
- Critical condition
- Visible skull fracture
- Failure or inability to provide signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pineta Grande Hospital
Castel Volturno, CE, Italy, 81030
Actively Recruiting
Research Team
F
Fabrizio Alfieri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here