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)
Phase: NA
Conditions: Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
Sponsor: B&B srl

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PROTOCOL 
TES-HT 100 MEDICAL DEVICE CLINICAL INVESTIGATIONS 
 
 
 
Title of Study: 
"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) 
Reference number or identification 
code of the clinical investigation: 
 CLV-01-TES HT 
 
Protocol version number: 
1.2 
 
Date of issue: 
27/01/2026 
 
Promoter 
Manufacturer and Sponsor: B&B S.r.l. 
Fienile road, 1 - 80013 - Casalnuovo (NA) 
+39 081-19189806 
 
Scientific Responsible 
DR.SSA CONTE MODESTINA ADRIANA  
Centers involved and Principal Investigators 
 
Center 1 - Emergency Room, Pineta Grande Hospital, Castel Volturno (Italy) 
Principal Investigator: Dr. Conte Modestina Adriana  
Investigators: Dr. Carmellino Salvatore, Dr. Perrone Anna, Localzo Angelo, Russo Esau, Dr. 
Antonia Sorbo 
 
Center 2 - Emergency Department, Upper Silesian Medical Center, Ochojec (Poland) 
Principal Investigator: dr n. med. Mateusz Majewski 
Study Coordinator: Paweł Nowicki 
Sub-investigators: Monika Nowicka, Anna Lis, Luiza Chmielewska, Bartek Blada, Tomasz 
Ilczak, Magdalena Augustyn, Amadeusz Żak, Urszula Uchwat, Małgorzata Cisowska, 
Katarzyna Maciejewska, Łukasz Basta, Norbert Ziółkowski, Tomasz Zawadzki, Jolanta 
Wołosianka, Jakub Gittner  
 
Center 3 - Emergency Department, Medical University of Gdańsk (Poland) 
Principal Investigator: prof. dr hab. n. med. Mariusz Siemiński 
Study Coordinator: Paweł Nowicki 
Sub-investigators: Jacek Szypenbejl, Piotr Woźniak 

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Contact Information 
 
Name Contact Promoter 
Bruno Basile 
bruno.basile@temnografia.com 
 
 
Name Contact for Vigilance 
Device 
Fabrizio Alfieri 
fabrizio.alfieri@temnography.com 
 

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PROTOCOL APPROVAL 
The Investigators and the Promoter: 
- 
Approve this Protocol; 
- 
declare that the study will be conducted in accordance with Good Clinical Practices, 
the UNI EN ISO 14155:2012 standard, and as stated in this Protocol. 
 
 
Bruno Basile 
27/01/2026 
Date 
 
DR Modestina Adriana Conte 
27/01/2026 
Date 
 
 
 
Date 

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Index 
Medical device information 
5 
Information regarding the manufacturer 
6 
Intended use and population for which the device is intended 
6 
Detailed description of the device 
6 
Mechanism of action 
8 
Training required for the use of the medical device by users 
8 
Literature review and rationale for clinical investigation 
9 
Objectives of the study 
11 
Ethical considerations 
11 
Methods for obtaining informed consent 
11 
Preclinical evidence and previous clinical experience 
12 
Information regarding the clinical investigation 
13 
Description of the study 
13 
Primary and secondary objectives 
14 
Variables to be measured 
16 
Systematic errors - bias 
16 
Patient selection 
16 
Inclusion criteria 
16 
Exclusion criteria 
16 
Number of patients expected to be enrolled 
17 
Point of enrollment 
17 
Number of experimental medical devices expected to be used 
17 
Duration of the study 
18 
Medical and surgical procedures and study follow-up 
18 
Discontinuation and withdrawal of subjects from clinical investigation 
19 
Benefit-risk assessment 
19 
Statistics 
19 
Quality assurance, control procedures, data management and record keeping 
21 
Deviations from the clinical evaluation plan 
22 
Adverse events 
22 
Data publication policy 
23 
Bibliography 
24 

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Device information medical 
The device under clinical investigation is the TES HT, model 100, equipped with software version 1.3 
(or later) and firmware version 1.4 (or later). The hardware and software configuration used in the 
study coincides with that planned for commercialization. 
TES HT model 100 devices are medical devices aimed at noninvasive detection of endocerebral 
lesions. It uses nonionizing, ultra-low-power electromagnetic waves in the frequency range of 5 0 0 -
6 5 0 0  MHz. 
TES HT devices are composed of the following parts: 
● Graphic measurement and data processing console; 
● Battery charger/power supply. 
The console inside includes the battery pack, radio frequency management and emission unit, 
processing unit, and a high-resolution display. 
The indication of the presence of an intra-cranial lesion is 'on-off' type.  
The positioning of the device is done manually by the operator (following the instructions in the 
Instruction Manual) as shown in Figure 1(a,b); the patient wears a disposable surgical-type headset 
while performing the examination, and the device never comes into direct contact with the patient's 
head. The complete examination has a duration of 5 minutes. 
 
 
 
 
Figure 1-(a) Correct positioning TES HT100 
Figure 1-(b) Wrong positioning TES HT100 

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Information related to manufacturer 
TES HT100 medical devices are mass produced by B&B Ltd. Information about the manufacturer is 
shown in Table 1. 
Table 1 
 
Company name 
B&B S.r.l. 
Company headquarters 
Fienile road, 1 - 80013 - Casalnuovo (NA) 
VAT number or tax code 
06342121214 
PEC 
bandbroadcast@pec.it 
Office Tel. 
+39 081-19189806 
E-mail 
direzione@temnografia.com 
Website 
https://www.bandbsrl.com/ 
 
Intended use and population for which the device is intended 
The TES HT100 medical device is designed to rapidly identify brain lesions and/or potentially 
pathological changes in brain structure. TES HT models are designed to measure the interaction of 
electromagnetic waves with a person's brain under static conditions. They are intended for 
emergency units, such as ambulances, first aid stations, neurology, trauma and emergency medicine 
departments - including mobile ones. The devices can be used several times on the same patient 
without time limitation. 
 
Detailed description of the device 
The TES HT 100 device consists of Console and Charger. Table 2 describes the technical specifications 
of the TES HT100 device. 
 
Table 2 
 
Technical Specifications TES HT100 
Specifications 
Dimensions (mm) 
420L x 400H x 340P 
Weight (kg) 
8.0 
Power supply (V) 
12V DC 
Battery (mAh) 
10000 mAh 
Power (W) 
60 

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Signaling of the presence of intra-cranial lesion or abnormality is 'on-off' type.  In the case of positive 
detection, the LED light clusters will signal this event by emitting a flashing red light signal; on the 
other hand, in the case of no negative outcome, they will signal this event by emitting a flashing green 
light signal. The report produced in PDF format is stored in the instrument and can be sent via internet 
connection to the prepared center at the end of the examination. 
In TES-HT 100 devices there are components such as electromagnetic transducers, the control module, 
the electronics for transducer management, the power button (amber in color), the examination 
start/stop button (blue in color), and two sets of optical indicators that signal the status of the system 
at each stage of operation. 
In terms of user interaction, the TES-HT 100 offers full functionality through the integrated physical 
buttons and also features a graphical touchscreen display, which allows for a graphical visualization of 
all phases of device operation  
 
Figure 2- TES-HT 100 device 
 
Technical Specifications TES HT100 
Specifications 
Radio Transmitter 
Precision Analyzer 
Radio wave frequency (MHz) 
500 - 6500 
Maximum power of radio waves (mW) 
250 
Screen 
10.1" 
Connection 
Internal Modem - SIM 
Maximum number of exams that can be stored 
1000 
Cable length (mm)  
 
Battery charger -> console =905 
power supply -> battery charger =1180 
Power supply weight (kg) 
0,35 
Power supply (V)  
220 A.C.-12 D.C. 

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Table 3 shows the materials used in the manufacture of the TES-HT 100 device  
 
Table 3-Device materials 
 
 
Action mechanism 
The technology of TES-HT devices is based on electromagnetic scattering over different dielectric 
tissues. Radiofrequency waves can easily penetrate the bone material of the cranial theca to reach 
the underlying tissues. Moreover, the dielectric composition of the brain is almost uniform, whereas 
blood and serum (for parenchymal lesions) have completely different "εr and σ (S/m)" dielectrics. 
This makes it possible to detect them within the brain with high contrast. Signal scattering in different 
frequencies and RF wave propagation are used in the specified range as 'radar' to detect 
abnormalities in the brain. The full range of frequencies used consists of hundreds of different 
frequencies. Each signal has a maximum sent power of less than 250 milliwatts. The complete 
diagnostic examination takes four minutes, and in this short time the total energy applied is minimal 
and discontinuous. 
Training required for the use of the medical device by users 
TES-HT 100 devices are designed and manufactured to be used by health care professionals without 
specific expertise. They allow the return of an automatic on/off type result regarding the presence of 
endocelebral lesions. 
The steps for setting up and properly performing the examination will be explained to the personnel 
who will use the device at dedicated training event. 
Copies of the user manual and a quick user guide will be provided with the device.  
 
Materials Bulletin Device 
● Mechanical structure 
● 2 electromagnetic transducers 
● Electronic control board 
● Cables 
● Button with integrated amber-colored LED 
● Button with integrated blue color led 
● Electronic control board 
● Processing Unit 
● RF signal generation system 
● Display module, Human Interface Device (HID) 
● Mechanical containment structure of the console 
 ●    Lithium-ion battery 12V, 10 A/h  

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Analysis of the literature and rationale for clinical investigation 
Mild head trauma 
Mild traumatic brain injury (mTBI) is a significant medical condition that requires detailed analysis to 
fully understand its clinical, epidemiological, and management implications. This type of trauma 
represents a major cause of disability and mortality worldwide, with an incidence that varies 
significantly, reaching up to 694 cases per 100,000 population per year (1). Despite the term "mild," 
head trauma of this type can lead to serious short- and long-term consequences, underscoring the 
importance of accurate diagnosis and appropriate treatment (2) 
The assessment of head injury severity is commonly based on the Glasgow Coma Scale (GCS), which 
classifies injuries into mild (GCS 13-15), moderate (GCS 9-12) and severe (GCS <8) (3). In Italy, each 
year, approximately 250 patients per 100,000 inhabitants require hospitalization due to head trauma, 
with a bimodal distribution by age, peaking between 16-35 years of age and over 70 years of age (4). 
The diagnosis of mild head trauma is mainly based on clinical manifestations such as loss of 
consciousness, amnesia, confusion, and altered mental status. The most common symptoms include 
confusion, amnesia, headache, dizziness, nausea and vomiting (5,6,7). Computed tomography (CT) 
scan is considered the gold standard for the diagnosis of head trauma (8). To improve diagnostic 
accuracy and reduce unnecessary radiation exposure, clinical scores such as the Canadian CT Head 
Rule (CCHR), the New Orleans Criteria (NOC), and the National Emergency X-Radiography Utilization 
Study II (NEXUS II) criteria have been developed and validated to identify patients in need of CT (9,10). 
However, a systematic review of the literature estimated a prevalence of CT abnormalities of 5% 
among patients with GCS = 15 and 30% for those with GCS = 13 (11). 
Importantly, despite the classification 
of mild head injury, this condition may 
hide important short- and long-term 
risks for the patient, underscoring the 
importance 
of 
more 
thorough 
evaluation 
and 
management 
of 
patients with this condition (12). Other 
neurological conditions that may 
manifest with symptoms similar to 
those of mild head injury are given by: 
Syncope, for example, represents a 
temporary loss of consciousness due 
to transient cerebral hypoperfusion, 
and its prevalence in the general 
population is estimated to be around 3 percent per year (13). Spatial disorientation and loss of balance 
can result from various neurological conditions, including stroke, vestibular diseases, and 
neurodegenerative disorders. It is estimated that about 30 percent of elderly patients aged 65-74 
years and up to 50 percent of those over 75 years have balance disorders (14). These symptoms, if 
neglected, can lead to serious complications, underscoring the importance of timely and accurate 
evaluation. 

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Speech disturbances, such as aphasia, and facial hemi-paresis are characteristic symptoms of stroke. 
Early intervention within 3-4.5 hours after symptom onset can significantly improve functional 
outcomes and reduce the risk of permanent disability (15). Stroke is a major cause of disability and 
mortality, with a huge impact on both individual health and overall health care expenditures (16). 
Approximately 30% of stroke patients have visual disturbances (17). Detailed assessment of these 
symptoms is critical to determine the underlying cause and plan appropriate treatment in order to 
preserve visual function and prevent further neurological damage. 
Head trauma can cause various neurological disorders, including memory loss, particularly when 
associated with traumatic brain injury (TBI). It has been shown that even a single traumatic event can 
cause structural and functional damage to the brain, thereby impairing short- and long-term memory 
(18). Head trauma has been shown to increase the risk of developing neurodegenerative diseases, 
such as Alzheimer's disease, which is often associated with cognitive deficits, including memory loss. 
In recent decades, several technological solutions have been explored for the development of 
portable, noninvasive devices aimed at detecting endocranial injury and/or stroke. [19,20] Among the 
multiple options, the technology that has demonstrated clinically relevant results is on the use of 
electromagnetic fields at microwave frequencies. Extensive studies have shown the ability of this 
approach in detecting lesions such as internal bleeding and edema by exploiting the dielectric contrast 
between different tissue types [21]. 
As highlighted in [22], the use of radar imaging technology allows the detection of hot spots where 
there is inhomogeneity of electromagnetic characteristics, such as the presence of blood in the brain 
parenchyma. Recording these variations, combined with the use of an appropriate imaging algorithm 
and a hybrid method for reducing reflections generated by surface structures (e.g., such as the skin) 
allows one to distinguish healthy tissue (dielectric values of various human tissues have been widely 
characterized in the literature) from diseased tissue [23]. 
 
Rationale for the investigation 
The objective of this clinical investigation is to validate the effectiveness of the TES HT100 device as a 
screening tool for the presence of brain injury both in patients with mild head injury and on patients 
with neurological symptoms not related to head injury. Having at one's disposal a rapid diagnostic 
address tool, only 5 minutes per examination, portable, nonoperator dependent, and most 
importantly harmless because it uses very low energy nonionized radio frequencies, that would allow 
rapid objective screening for the presence of brain lesions would allow for improved management of 
such patients afferent to the emergency department. Such instrumentation would allow rapid 
identification of patients, who even if not in critical situations, need further diagnostic investigation. 
The literature supports the need for advanced diagnostic tools that can assist clinicians in the rapid 
and accurate assessment of complex neurological conditions. The rationale for this investigation is 
based on the need to improve the quality of care provided to patients with mTBI and other 
neurological conditions. The TES HT100 device interposes itself as an initial screening tool for the 
detection of brain lesions and neurological disorders potentially related to them, potentially enabling 
targeted management of patients. In addition, the adoption of the TES HT100 could lead to greater 
efficiency in the area of healthcare resources by reducing waiting times for diagnosis and optimizing 

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the use of diagnostic equipment. This could result in better utilization of hospital resources and an 
overall improvement in the quality of care provided to patients. 
 
Objectives of the study 
Clinical validation of the ability of TES HT 100 to identify brain injury or alterations in brain structure 
in patients with: 
• mild head trauma  
• neurological symptoms not attributable to trauma but not in critical condition. 
Considerations ethics 
The clinical trial of the TES-HT device is performed in compliance with the Standards of Good Clinical 
Practice (GCPs) and all other applicable regulations and administrative requirements. 
The sponsor declares compliance with the Code of Good Clinical Practice for planning and 
conducting clinical investigations of medical devices in accordance with UNI EN ISO 14155:2020, 
Regulation (EU) 2017/745, and ICH-GCP guidelines, where applicable. 
 
Modalities for obtaining informed consent. 
Subject participation in this clinical study is voluntary. 
Informed consent is obtained prior to the use of any experimental device, required by the study 
and/or test procedures or data collection. 
Obtaining and documenting informed consent must be in accordance with the principles of 
ICH/GCP, the Declaration of Helsinki, and ISO 14155. 
B&B S.r.l. will provide researchers with a specific Informed Consent Form for volunteers 
participating in this study. Any changes by the Sponsor require acceptance by B&B S.r.l. prior to 
use of the Template. The Template must be in a language understandable to the subject.  
The process for obtaining informed consent includes: 
• be conducted by personnel assigned or authorized to conduct the trial; 
• include a description of all aspects of the clinical trial that are relevant to the subject's decision 
to participate in the entire clinical trial; 
• avoiding any coercion or undue influence of subjects to participate; 
• not waive or give the impression of waiving the subject's legal rights; 
• use language that is simple and understandable to the subject or the subject's legal 
representative; 
• provide time for the subject to consider participation and ask questions if necessary. 
This Form must always be personally signed and dated by the subject or legal representative and 
the investigator and/or authorized designee. The original signed copy will be retained by the 
Sponsor. Failure to obtain subject consent will be reported by the Sponsor to the appropriate 

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regulatory body as required by them. 
 
Preclinical evidence and previous clinical experience  
The TES-HT100 device was initially subjected to a series of validation tests using phantoms designed 
to accurately replicate the properties of the human tissues of interest. For the generation of such 
phantoms, which replicate the dielectric characteristics of the head, values found in the specialist 
literature were adopted [24]. As previously published studies have shown, the use of such phantoms 
allow laboratory replication of close-to-reality clinical situations of injuries such as hematomas, 
contusions, and diffuse damage Laboratory experimental results validated the device's ability to 
successfully detect alterations in endocranial dielectric properties, with high specificity and sensitivity. 
These data are available as Internal data from B&B s.r.l. 
For the fulfillment of essential safety requirements in accordance with European Regulation MDR 
745/2017, a campaign was conducted to analyze, assess, and manage risks arising from the intended, 
reasonably foreseeable, and unforeseen use of the TES-HT100 device. Controls were defined and 
implemented to mitigate the identified risks. Residual risks are found to be acceptable in accordance 
with international standards and guidelines for risk management (ISO IEC 14971:2022). To ensure 
mechanical and electrical safety, the device was tested at laboratories for compliance with IEC 60601-
1 standards, which cover general requirements for basic safety and essential performance of 
electromedical devices. These tests included checks for mechanical strength, electrical safety, 
protection against fire and electric shock hazards, and general robustness of the device. The device 
underwent electromagnetic compatibility testing according to IEC 60601-1-2 standards. These tests 
ensure that the TES-HT100 does not interfere with other medical devices and is resistant to 
electromagnetic interference. Validation fates of the software and the Usability of the graphical user 
interface were conducted. Then The device was tested on a group of 98 volunteers at the Magnolia 
Clinic. in a real clinical environment. The volunteers were monitored for the presence of neurological 
symptoms and brain lesions using TES-HT100. The data collected indicated high accuracy an excellent 
tolerability of the device, with no significant adverse effects. [25] Currently, TES-HT100 is the subject 
of a clinical investigation, conducted according to Good Clinical Practice ISO 14155, to EU Regulation 
2017/745 following the clinical investigation guidelines MEDDEV 2.7/1 rev. 4. This study was approved 
by the Regional Ethics Committee for Clinical Trials of Tuscany-Italy Region on 17/04/2023. Preliminary 
data from that study, on 20 patients presented as an oral communication at the SIMEU congress 
(abstract ID 018) show that the device a near 100% congruity with CT outcome. [26] 
 
 
Investigation information clinical 
TES-HT devices are capable of detecting brain lesions. The answer is YES/NO. 
Three different steps must be considered during the clinical investigation: 
 

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1) Data collection - In order to achieve the target number established with the Reference 
Sponsor. 
2) Data processing and comparison - At this stage, data are processed for each patient using 
appropriate ID, and the result is linked to the respective diagnosis by the relevant 
personnel at the institution hosting the survey. 
 
The purpose of the clinical investigation is to commercialize the device on a national/international 
scale. 
 
Study Description. 
The aim of the multicenter, open-label study is to clinically validate the TES HT100 as a screening 
tool for noncritical care patients attending the emergency department or for mild head injury or 
neurological symptoms.  
The study involves the enrollment of two separate cohorts of patients in the following centers: 
• Center 1 - Emergency Department, Pineta Grande Hospital, Castel Volturno (Italy) 
• Center 2 - Emergency Department, Upper Silesian Medical Center, Ochojec (Poland) 
• Center 3 - Emergency Department, Medical University of Gdańsk (Poland) 
 
The study involves the enrollment of two separate cohorts of patients: 
1) 425 Patients with mild head injury 
2) 425 Patients with neurological symptoms not related to head trauma and not in a critical or life-
threatening condition such as: 
• Syncope 
• Spatial disorientation and loss of balance 
• Speech disturbance and facial hemi-paresis 
• Visual impairment 
• Lack of memory and confusional state 
 
As an indication, an enrollment of approx: 
- [275] patients per cohort at Pineta Grande Hospital 
- [75] patients per cohort at GCM Ochojec 
- [75] patients per cohort at Medical University of Gdańsk. 
 
All patients will follow the normal diagnostic-therapeutic procedure with priority access to CT 
examination according to severity and to which, as described below, only the examination with TES 
HT100 will be added, which has a maximum duration of 5 min (examination duration 4 min for 
acquisition and 1 min for data processing): 
 
Patients with mild head trauma:  
* the patient with mild head trauma following Acceptance Acceptance will be assisted and evaluated 
at Triage and will have a CT scan within 1 hr or more, followed by themnographic examination with 

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TES HT100, after signing informed consent for participation in the study; 
 
Patients with neurological symptoms:  
* the patient following Acceptance Acceptance will be assisted and evaluated at Triage and a CT 
scan will be performed in order to exclude the possible presence of stroke and, with reference to 
patients enrolled in the Pineta Grande Hospital emergency room, possible transfer via 118 to the 
Stroke Unit U.O.S.D. | A.O.S.G. Moscati. For the other 2 centers that have stroke units, patients will 
be transferred to the relevant departments. The temnographic examination with TES HT100 will be 
performed after the CT scan during the CT reporting phase, after signing the informed consent for 
participation in the study.  
 
The TES HT100 examination will be performed by trained personnel, who will not have access to 
the CT report at the time of the examination with TES HT100. 
The radiologist reporting the CT scan will be blinded to the TES HT100 result. TES results will be 
made available only after the CT report has been finalized and recorded. 
 
Information on the data collection form (Appendix A) will be collected for each patient. 
 
Primary and secondary objectives 
 
Primary objectives. 
 
• To evaluate the diagnostic accuracy of the TES HT100: To measure the sensitivity and 
specificity of the device in identifying brain lesions and structural brain changes in the cohorts 
of patients included in the study. 
• To establish the safety of TES HT100: To monitor the incidence and type of possible adverse 
events associated with the use of the medical device during the study. 
 
Secondary Objectives. 
• 
To evaluate the benefit of clinical use of the TES HT100: To measure the efficiency of the 
device in improving the management of patients and hospital resources in the emergency 
department setting during patient screening. 
• 
To evaluate the diagnostic accuracy of the TES HT100 in various patient subgroups: 
o Young patients (<65 years old) 
o Elderly patients (>65 years) 
o Patients with or without prior injury or undergoing brain surgery 
o Patients with or without neurodegenerative diseases 
Primary endpoints 

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• 
Receiver Operating Characteristic-Area under curve (ROC-AUC) processing, depending on the 
sensitivity and specificity calculated by comparing the TES HT100 exam result versus the CT scan 
report. 
• 
In order to establish the safety of the medical device, the rate of adverse events related to the 
use of TES HT100 will be calculated as provided in Regulation 2017/745 (MDR) (CNCCE Circular No. 
4/2022) 
 
Secondary endpoints:  
• 
Descriptive evaluation of the potential benefits of using TES HT100 calculated as a function of 
the possible benefit applicable to each patient, in terms of operator time, procedures, and costs, 
that would be obtained by performing examination with TES HT 100 with the aim of directing the 
patient to the most appropriate diagnostic pathway. 
• 
Analysis of the diagnostic performance of TES HT100 as a function of sensitivity and 
specificity calculated by comparing the TES HT100 exam result versus the CT scan report in 
subgroups of patients 
Target Definition: 
 
For the purpose of evaluating the diagnostic performance of TES HT100, the reference test (gold 
standard) is the encephalic computed tomography (CT) report. 
 
All patients with at least one of the following acute or potentially clinically relevant intracranial 
lesions will be considered "CT-positive": 
- intraparenchymal, subdural, and subarachnoid hemorrhage; 
- cerebral contusion with edema; 
- calcifications; 
- presence of nodules of various nature (eg cysts); 
- acute or subacute or previous cerebral ischemia; 
- other acute or prior intracranial injuries, 
 
Patients without such findings will be considered "CT-negative" 
 
Expected Results. 
In a health care perspective of rationalization of resources, the TES HT 100 tool could be useful to 
identify from the outset patients on whom to prioritize the diagnostic pathway, avoiding delays and 
at the same time avoiding dispersion of resources in terms of economics and staff time for the 
management of patients who do not need in-depth diagnostic investigation. We assume a 
diagnostic reliability of TES HT 100 greater than or equal to 90% and a sensitivity and specificity 
greater than 80%. 
Technological developments in the medical field reflect the need to enhance the diagnostic field 

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with the introduction of diagnostic tools that are increasingly accessible, objective, fast and reliable, 
and above all harmless to the patient and health care providers.  
 
Variables to be measured 
TES HT examinations should be performed within 24 hours before or after the CT examination.  
Systematic errors - bias 
Systematic errors that may occur during the study are mainly related to the marked movement of 
the patient, who should avoid abrupt movements throughout the scan in order to reduce motion 
artifacts. 
 
Patient selection 
 
Patient inclusion criteria: 
 
Group 1: 
- age over 18 years 
- acquisition of informed consent 
- Patients referred to the emergency department for mild head injury  
 
Group 2: 
- age greater than 18 years 
- acquisition of informed consent 
- Patients afferent to the emergency department not for head trauma and not in a critical 
condition, with one of the following neurological symptoms: 
• Syncope 
• Spatial disorientation and/or loss of balance 
• Speech disturbance and/or facial hemi-paresis 
• Visual alterations 
• Lack of memory and/or confusional state 
 
Exclusion criteria for both cohorts: 
 
- age less than 18 years 
- pregnant women 
- metal plates or metal prostheses installed in the skull cap 
- severe head trauma and/or with extensive lacerated contused areas 
- patient in critical condition 
- visible skull theca fracture 

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- failure to sign informed consent 
 
The TES-HT device cannot be used in cases of metal plates or metal prostheses installed in the 
skullcap because their presence alters the outcome of the TES HT100 examination. 
Number of patients expected to be enrolled 
Considering that it is intended to prove the primary hypothesis that TES HT 100 succeeds in 
achieving a sensitivity and specificity of 90% when comparing to the outcome of the CT scan report, 
an AUC of 0.90 is obtained, a value indicative of its excellent reliability. Assuming that TES HT100 
meets this performance, a sample size of about 384 subjects is needed to obtain a maximum error 
of 3% on the confidence interval in the 95% two-tailed test on AUC. In other words, the target AUC 
and sample size should allow 95% confidence that the AUC is within the range [0.87;0.93]. Given a 
10% drop-out rate, a sample size of 425 subjects for each patient cohort is considered necessary. 
Although the sample size calculation was performed as was previously explained, we believe it is 
fair to consider, in the case where there is a large imbalance between positive and negative 
outcomes, a small adjustment on the precision of the AUC estimate. Specifically, we will consider a 
precision of 0.02 instead of 0.03.  
 
Enrollment point 
Patients will be enrolled in the following emergency departments: 
- Pineta Grande Hospital, Castel Volturno (Italy) 
- Emergency Department, Upper Silesian Medical Center, Ochojec (Poland) 
- Emergency Department, Medical University of Gdańsk (Poland). 
The patient is understood to be enrolled in the clinical trial from the moment he or she meets all 
inclusion and exclusion criteria and after signing the Informed Consent Form at the relevant center.  
 
Number of experimental medical devices expected to be used. 
Three TES HT100 devices are planned for the study, one for each participating center. All devices 
will be of the same hardware and software version and will undergo the same qualification and 
maintenance procedures. 
 
Duration of the study 
The study is planned to last 30 months. 
 
Medical and surgical procedures and follow-up of study 
After positioning the device and the patient at the correct height, the authorized  healthcare 
personnel press the P1 button (Figure 3) to start the measurements.  
The device signals the measurement status through the L1 and L2 indicator, which emits a flashing 
blue light optical signal.  

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After the first measurement, the device gives the result of injury detection. After the end of the 
measurement operation, the user can remove the device and the examination is finished. To turn 
off the device, the user presses the appropriate button. After using the device, the user stores the 
device in a safe environment with the following requirements: 
● temperature 0°-+50° and humidity max 90%; 
● the device does not require cleaning agents; just follow the instructions in the Manual 
for common cleaning; 
● the patient can wear a disposable surgical cap. 
 
The TES HT100 examination will be performed by trained personnel, who will not have access to the 
CT report at the time of the TES HT100 examination. 
The radiologist reporting the CT scan will be blinded to the TES HT100 result. TES results will be 
made available only after the CT report has been finalized and recorded. 
L1 
L2 
P
1

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Discontinuation and withdrawal of subjects from clinical investigation 
In case of premature termination of studies, a Written Statement as to the reason for the premature 
termination of the trial must be produced. Community and regulatory authorities, as appropriate, 
will be informed. Detailed information on how enrolled subjects will be handled will be provided 
later. In the event that the Sponsor discontinues participation in the study, TES-HT staff and 
regulatory authorities, as appropriate, will be informed in writing. 
 
Evaluation benefit-risk 
In consideration of risk/benefit, the TES-HT device appears to be absolutely harmless to both patient 
and operator. In fact, throughout its operation, the electromagnetic emission values are well below 
the electromagnetic emission values for professional electromedical devices. 
The benefits that emerge from using the device can be divided into: 
1) Ease of use - The device is easy to set up and its use does not require specialized personnel. 
2) Low risk to the patient - The device does not emit ionizing radiation (as in the case of CT 
scanning) and emission levels are well below reference limits. 
3) Short scan duration - The duration of one measurement is 4 minutes. 
4) Small size and easily transportable - The small size makes TES HT a device that can be used 
in all emergency situations and in places where rapid transport to a First Aid Center is 
difficult. 
The device shows, therefore, that the cost-benefit is positive and the results timely and beneficial. 
 
Statistics 
To evaluate the performance of the device, statistical sensitivity and statistical specificity will be 
calculated. Statistical sensitivity indicates the device's ability to correctly identify positive cases, i.e., 
patients with brain injury (prior or post injury) and/or structural alteration of brain tissue. Statistical 
specificity indicates the ability of the 
device to correctly identify negative cases, i.e., patients without brain injury (new or prior) and 
without structural alteration of brain tissue. All TES HT examinations will be compared with the CT 
scan report, which will sanction the actual presence or absence of structural alterations of brain 
tissue. Comparison criteria such as Receiver Operating Characteristic-Area under curve (ROC-AUC), 
sensitivity and specificity will be used as statistical validation tools, all reported with 95% confidence 
interval for the entire enrolled population ("pooled" multi-center analysis). The ROC-AUC will be 
calculated using, as a continuous score, the percentage of cranial bone estimate (Q) generated by 
the TES HT software (as a surrogate for measurement quality) for each examination; in supportive 
analysis, the probability of CT-positive outcome can be modeled by logistic regression including the 
TES outcome (positive/negative) and Q as a continuous covariate. For this purpose, we want to 
demonstrate the primary hypothesis regarding a diagnostic performance of the TES HT 100 not less 
than 90% ROC-AUC compared to the outcome of the CT report, while maintaining sensitivity and 

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specificity of at least 80%. The minimum threshold of 90% is indicative of excellent instrument 
reliability.   
To calculate the statistical sensitivity and specificity, the following data will be used: 
 
Brain injury present 
Brain injury absent 
Positive test 
TP (True Positive) 
FP (False Positive) 
Negative Test 
FN (False Negative) 
TN (True Negative) 
Total 
TP+FN 
FP+TN 
 
• Number of true positive cases (TP): number of patients with brain injury (prior or post injury) 
and/or structural alteration of brain tissue correctly identified by device and confirmed by CT 
scan 
• Number of false-negative (FN) cases: number of patients with brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue not identified by the device but 
confirmed by CT scan 
• Number of false-positive (FP) cases: number of patients without brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue identified as positive by the device 
but confirmed as negative by CT scan 
• Number of true negative cases (TN): number of patients without brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue correctly identified by the device and 
confirmed by CT scan 
 
Statistical sensitivity is calculated as TP/(TP+FN), while statistical specificity is calculated as 
TN/(TN+FP). 
It will also be calculated: 
- 
the positive predictive value: probability that the disease is present when the test is positive 
calculated as TP/(TP+FP) with 95% confidence interval. 
- 
the negative predictive value: probability that the disease is not present when the test is 
negative as TN/(FN+TN) with 95% confidence interval. 
Specificity and sensitivity, with 95% confidence interval, will also be evaluated for different 
subgroups of patients enrolled such as: 
- 
Young patients <65 years old 
- 
Elderly patients >65 years old 
- 
Patients with or without prior injuries or who have undergone brain surgery 
- 
Patients with or without neurodegenerative diseases 
- 
Patients enrolled by center 

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In exploratory secondary analysis, the variable "center" may be used: 
- as a stratification factor for describing device performance at individual sites; 
- as a covariate in statistical models to assess the presence of any systematic differences between 
centers. 
 
An interim analysis is planned for the respective cohorts of patients under study when the 
thresholds of 150 and 300 patients enrolled in each cohort are reached. 
 
Quality assurance, control procedures, data management and retention of documentation 
Subjects' data will be collected through a centralized Electronic Data Capture (EDC) system, which 
allows the enrollment center to be identified through a site code. 
The coordinating center, in collaboration with the Sponsor, will ensure harmonization of 
procedures among centers by: 
- initial and periodic training of investigators; 
- in-person and/or remote monitoring; 
- centralized review of data quality. 
Each center will maintain its own Investigator Site File (ISF), while the Sponsor will maintain the 
overall Trial Master File (TMF). 
All changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the Sponsor or its representative. The software and database associated with data 
acquisition and storage are designed to meet compliance with applicable laws and regulations, 
regarding data processing. Data collected on study subjects are in accordance with the ICH/GCP 
Guidelines valid in the European Union. Records must be kept for ten years after completion of 
the device trial. 
 
Each data collected should contain: 
● ID of the examination performed on TES-HT (ID generated by TES-HT for each examination); 
● Examination location (emergency district or other), time, date and operator. 
● Anonymous patient history 
● Enrollment center identification code ("center variable") 
 
Deviations from the assessment plan clinical 
An investigator must not make changes to or deviate from this Protocol except to protect the life 
and physical well-being of an emergency subject. An investigator must notify both the Sponsor 
and the manufacturer of any major deviation from the investigative plan designed to protect the 
life or physical well-being of a subject in an emergency. 
Such notice will be given as soon as possible, but no later than 5 working days after the emergency 

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occurs. 
All deviations from the investigation plan, with the reason for the deviation must be collected in 
the appropriate document, which must contain: 
● patient data; 
● place, date and time; 
● signature of the investigator. 
Deviations will be reviewed and evaluated on an ongoing basis, and corrective and 
preventive procedures will be applied if necessary. 
Deviations will be classified according to the following definitions: 
• 
Type A - Deviation to protect the life or physical well-being of a patient in unforeseen 
emergency. 
• 
Type B - Deviation based on medical judgment. 
• 
Type C - Deviation due to misunderstanding of Protocol requirements. 
• 
Type D - Deviation due to an out-of-control situation. 
• 
Type E - Deviation due to oversight, error or non-compliance of the Protocol. 
 
Patient flow and enrollment diagrams. 
In order to transparently describe the path of patients within the study, a flow chart will be prepared 
in accordance with international recommendations for diagnostic accuracy studies. The chart will 
report, for each of the two cohorts (mild head injury and nontraumatic neurological symptoms) and 
for the entire population: 
- the number of patients evaluated for eligibility; 
- the number of patients excluded, with the main reasons (e.g., exclusion criteria, lack of consent, 
inability to perform TES or CT scan); 
- the number of patients enrolled who performed both HT100 TES and CT; 
- the number of patients with incomplete or non-assessable data for the primary analysis; 
- the number of patients included in the final statistical analysis. 
Where appropriate, the flow chart may be further detailed by enrollment center to highlight any 
differences in the inclusion and follow-up process among participating sites. The flow chart will be 
included in the final report and may be used in any scientific publications resulting from the study. 
 
Adverse Events  
The TES-HT device is a model of a temnographic device already in use in different settings for which 
no adverse events were observed. 
Adverse events (AEs), serious adverse events (SAEs), device-related serious adverse events 
(SADEs), and device deficiencies will be collected and classified according to the definitions in 
Regulation (EU) 2017/745 and UNI EN ISO 14155:2020. 
The principal investigator of each center is responsible for timely notification to the Sponsor of 
each SAE and SADE, within 24 hours of knowledge. The Sponsor, when required, will notify the 

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relevant authorities and ethics committees according to applicable national regulations.  
 
Publication policy of data 
B&B S.r.l. will submit a study of results for publication (regardless of the outcome of the 
investigation) after its conclusion or termination. B&B S.r.l. adheres to the established 
collaboration criteria of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org ).

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