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

Official title

TES HT100 Clinical Outcomes - Clinical Validation of the TES HT100 Temnograph for Brain Injury Screening in Patients With Mild Head Trauma or Suspected Neurological Symptoms (TESCO)

Overview

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

Detailed description

This is a prospective, multicenter, open-label clinical investigation evaluating the TES HT100 as a non-invasive adjunctive screening device for detection of intracranial abnormalities in adult Emergency Department patients. The study is being conducted in three centers in Italy and Poland.

TES HT100 is intended for non-invasive detection of endocerebral lesions. The device used in this investigation is TES HT model 100, equipped with software version 1.3 or later and firmware version 1.4 or later, in the same configuration planned for commercialization. The system uses non-ionizing, ultra-low-power electromagnetic waves in the 500-6500 MHz frequency range and provides a binary result indicating the presence or absence of intracranial abnormality. The examination is brief, with an overall duration of about 5 minutes.

The study is designed to evaluate the diagnostic performance and safety of TES HT100 when used in addition to standard emergency care. Participants undergo routine clinical assessment and brain CT according to usual clinical practice, and the TES HT100 examination is performed as an add-on procedure. The reference standard for performance evaluation is the brain CT report. TES HT100 is not intended to replace standard clinical assessment or CT imaging.

To reduce interpretation bias, the TES HT100 examination is performed by trained personnel who do not have access to the CT report at the time of testing, and the radiologist interpreting the CT scan is blinded to the TES HT100 result. TES HT100 examinations are performed within 24 hours before or after CT, according to site workflow.

The investigation plans to enroll approximately 850 participants overall across two clinical cohorts. The study duration is planned to be 30 months. Three TES HT100 devices, one per participating center, will be used under the same qualification and maintenance procedures.

In addition to diagnostic validation against CT, the study includes safety monitoring during device use and an exploratory assessment of the potential clinical utility of TES HT100 in emergency department triage and resource management. The overall objective is to generate clinical evidence on the performance and safety of TES HT100 as a rapid, non-invasive screening support tool in the emergency setting.

Interventions

• Diagnostic test 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 hea

Primary outcome measures

• Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities [Time frame: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT]
• Rate of device-related adverse events [Time frame: From TES HT100 examination through study participation completion, an average of 1 year]

Secondary outcome measures (4)

• Operator time associated with TES HT100-supported screening [Time frame: Day 1]
• Procedures associated with TES HT100-supported screening [Time frame: Day 1]
• Costs associated with TES HT100-supported screening [Time frame: Day 1]
• Diagnostic performance of TES HT100 in predefined patient subgroups [Time frame: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 1 center

• Pineta Grande Hospital — Castel Volturno

Publications

• Cuccaro A, et al. Microwave Radar Imaging as a Tool for Medical Diagnostics. Eng Proc. 2023.
• Solimene R, et al. An Incoherent Radar Imaging System for Medical Applications. IEEE CAMA 2021.
• Vaia S, Iavarone A, et al. HT temnography in the early diagnosis of brain lesions due to ischemic or hemorrhagic stroke. Int J Adv Res. 2023.
• Montemerani S, Fabrizi C, Sacchi C, Belperio A, Moriani L, Pacchi S, Garofalo C, Sbrana G, Venezia D, Zanobetti M, Nocentini S. Reliability Evaluation of Temnography for Early Detection of Intracranial Lesions in Mild Traumatic Brain Injury Patient: A Preliminary Report of a New Portable, Non-Invasive Device. Open Access Emerg Med. 2024 Dec 6;16:313-321. doi: 10.2147/OAEM.S475328. eCollection 2024 PMID 39659448
• Islam MS, Islam MT, Almutairi AF. Experimental tissue mimicking human head phantom for estimation of stroke using IC-CF-DMAS algorithm in microwave based imaging system. Sci Rep. 2021 Nov 10;11(1):22015. doi: 10.1038/s41598-021-01486-x. PMID 34759284
• Gabriel S, Lau RW, Gabriel C. The dielectric properties of biological tissues: II. Measurements in the frequency range 10 Hz to 20 GHz. Phys Med Biol. 1996 Nov;41(11):2251-69. doi: 10.1088/0031-9155/41/11/002. PMID 8938025
• Gabriel C, Gabriel S, Corthout E. The dielectric properties of biological tissues: I. Literature survey. Phys Med Biol. 1996 Nov;41(11):2231-49. doi: 10.1088/0031-9155/41/11/001. PMID 8938024
• Lefevre-Dognin C, Cogne M, Perdrieau V, Granger A, Heslot C, Azouvi P. Definition and epidemiology of mild traumatic brain injury. Neurochirurgie. 2021 May;67(3):218-221. doi: 10.1016/j.neuchi.2020.02.002. Epub 2020 May 6. PMID 32387427

Identifiers

NCT: NCT07490418 · CLV-01-TES HT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗