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Background <p>Emergency Department (ED) evaluation of patients presenting with mild head trauma or acute neurological symptoms is common and often requires rapid exclusion of intracranial pathology. Although computed tomography (CT) is the diagnostic reference standard, its widespread use raises concerns regarding radiation exposure, cost, and ED workflow efficiency. TES HT100 is a portable, non-invasive radiofrequency-based device intended to assist early triage decisions. We report the prespecified interim analysis of a prospective validation study conducted in an ED population.</p> Methods <p>Between December 2024 and January 2026, adult patients were enrolled at the Emergency Department of Pineta Grande Hospital, Castel Volturno, Italy. In this single-center, blinded diagnostic accuracy study, participants were included in two predefined cohorts: mild head trauma and non-traumatic acute neurological symptoms. TES HT100 provides a binary output and was compared with radiologist-interpreted head CT as the reference standard. Sensitivity, specificity, predictive values, likelihood ratios, accuracy, and balanced accuracy were calculated with 95% confidence intervals. Additional exploratory analyses stratified CT findings into acute clinically relevant abnormalities and chronic/incidental intracranial abnormalities without changing the prespecified primary endpoint. Robustness analyses assessed the impact of excluded or non-evaluable cases. Trial registration: ClinicalTrials.gov Identifier NCT07490418, registered on 23 March 2026.</p> Results <p>The interim analysis included 301 patients (151 trauma; 150 neurological symptoms). CT-positive prevalence was 52.2%, consistent with the CT-imaged Emergency Department population and the protocol-defined broad intracranial abnormality endpoint. Overall sensitivity was 96.2% (95% CI 91.9–98.2), specificity 82.6% (75.6–88.0), PPV 85.8%, NPV 95.2%, and accuracy 89.7%. The positive likelihood ratio was 5.54 and the negative likelihood ratio 0.05. Exploratory category-specific analyses showed sensitivity and NPV of 96.6% and 98.4%, respectively, for acute clinically relevant abnormalities, and 96.0% and 96.0%, respectively, for chronic/incidental abnormalities. Specificity was lower in the acute-target analysis (50.6%), supporting interpretation of TES HT100 as a structural-abnormality triage signal rather than a lesion-specific acute-pathology classifier.</p> Conclusions <p>In this interim evaluation, TES HT100 demonstrated high sensitivity and a low negative likelihood ratio compared with CT in ED patients with head trauma or acute neurological symptoms. These findings support further evaluation of TES HT100 as a triage-support adjunct in CT-imaged ED populations. Exploratory acute/chronic analyses provide additional clinical context but should not be interpreted as evidence of lesion-specific performance for acute abnormalities or as justification for replacing CT.</p>

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Prospective blinded interim evaluation of a portable radiofrequency device TES HT to support triage in emergency department patients with mild head trauma or acute neurological symptoms

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  • 发表日期：

    2026年7月7日

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  • Adriana Modestina Conte,
  • Fabrizio Alfieri,
  • Angelo Localzo,
  • Esaù Russo,
  • Iole Cucinotto,
  • Alessandro Trovato,
  • Riccardo Gualtieri,
  • Ettore Laccetti,
  • Antonia Sorbo

摘要

Background

Emergency Department (ED) evaluation of patients presenting with mild head trauma or acute neurological symptoms is common and often requires rapid exclusion of intracranial pathology. Although computed tomography (CT) is the diagnostic reference standard, its widespread use raises concerns regarding radiation exposure, cost, and ED workflow efficiency. TES HT100 is a portable, non-invasive radiofrequency-based device intended to assist early triage decisions. We report the prespecified interim analysis of a prospective validation study conducted in an ED population.

Methods

Between December 2024 and January 2026, adult patients were enrolled at the Emergency Department of Pineta Grande Hospital, Castel Volturno, Italy. In this single-center, blinded diagnostic accuracy study, participants were included in two predefined cohorts: mild head trauma and non-traumatic acute neurological symptoms. TES HT100 provides a binary output and was compared with radiologist-interpreted head CT as the reference standard. Sensitivity, specificity, predictive values, likelihood ratios, accuracy, and balanced accuracy were calculated with 95% confidence intervals. Additional exploratory analyses stratified CT findings into acute clinically relevant abnormalities and chronic/incidental intracranial abnormalities without changing the prespecified primary endpoint. Robustness analyses assessed the impact of excluded or non-evaluable cases. Trial registration: ClinicalTrials.gov Identifier NCT07490418, registered on 23 March 2026.

Results

The interim analysis included 301 patients (151 trauma; 150 neurological symptoms). CT-positive prevalence was 52.2%, consistent with the CT-imaged Emergency Department population and the protocol-defined broad intracranial abnormality endpoint. Overall sensitivity was 96.2% (95% CI 91.9–98.2), specificity 82.6% (75.6–88.0), PPV 85.8%, NPV 95.2%, and accuracy 89.7%. The positive likelihood ratio was 5.54 and the negative likelihood ratio 0.05. Exploratory category-specific analyses showed sensitivity and NPV of 96.6% and 98.4%, respectively, for acute clinically relevant abnormalities, and 96.0% and 96.0%, respectively, for chronic/incidental abnormalities. Specificity was lower in the acute-target analysis (50.6%), supporting interpretation of TES HT100 as a structural-abnormality triage signal rather than a lesion-specific acute-pathology classifier.

Conclusions

In this interim evaluation, TES HT100 demonstrated high sensitivity and a low negative likelihood ratio compared with CT in ED patients with head trauma or acute neurological symptoms. These findings support further evaluation of TES HT100 as a triage-support adjunct in CT-imaged ED populations. Exploratory acute/chronic analyses provide additional clinical context but should not be interpreted as evidence of lesion-specific performance for acute abnormalities or as justification for replacing CT.