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

March 18, 2026 updated by: B&B srl

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • CE
      • Castel Volturno, CE, Italy, 81030
        • Recruiting
        • Pineta Grande Hospital
        • Contact:
        • Principal Investigator:
          • Modestina Adriana Conte, MD
        • Sub-Investigator:
          • Angelo Localzo, Registered Nurse
        • Sub-Investigator:
          • Esaù Russo, Registered Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TES HT100 Examination
All enrolled participants receive standard emergency department evaluation, including head CT according to usual clinical practice, and undergo an additional TES HT100 examination as an add-on procedure. TES HT100 is evaluated against the head CT report used as the reference standard. The study includes adults with mild head injury and adults with neurological symptoms not related to head trauma and not in a critical or life-threatening condition.
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 head CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Diagnostic performance of TES HT100 compared with the head CT report as the reference standard, assessed by ROC-AUC and by sensitivity and specificity for identification of intracranial abnormalities.
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
Incidence and type of adverse events related to the use of TES HT100 during the study.
From TES HT100 examination through study participation completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator time associated with TES HT100-supported screening
Time Frame: Day 1
Descriptive evaluation of operator time associated with use of TES HT100 during emergency department screening, based on the number of TES HT100 examinations performed per participant and the approximate duration of each examination (about 5 minutes), as described in the protocol.
Day 1
Procedures associated with TES HT100-supported screening
Time Frame: Day 1
Descriptive evaluation of workflow-related procedures associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol. This may include patient handling or organizational procedures required during the diagnostic pathway, such as patient transfer to a different bed or room or need for additional staff support.
Day 1
Costs associated with TES HT100-supported screening
Time Frame: Day 1
Descriptive evaluation of resource use and related cost considerations associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol.
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
Analysis of TES HT100 diagnostic performance, based on sensitivity and specificity versus head CT, in predefined subgroups, including younger patients, older patients, patients with or without prior injury or brain surgery, and patients with or without neurodegenerative disease.
At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B&B srl

Investigators

  • Study Director: Fabrizio Alfieri, B&B srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLV-01-TES HT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified participant-level data may be shared upon reasonable request, subject to ethics and institutional approval where applicable and execution of a data sharing agreement. Public sharing is not planned due to confidentiality and consent restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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