Mild Traumatic Brain InjuryTESCONCT07490418
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
A study testing Temnographic Brain Screening Examination in people with Mild Traumatic Brain Injury and Intracranial Lesions, run by B&B srl at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- What is being tested?
- Temnographic Brain Screening Examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Dec 2024to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- speech disturbance and/or facial hemi-paresis
- visual alterations
- memory loss and/or confusional state
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Poland2 sites, 2 recruiting
- Not yet recruiting
Emergency Department, University Clinical Centre, Medical University of Gdańsk
Gdansk, 80-952
Paweł Nowicki, +48 730 505 991, nowicki.p@wp.pl
Mariusz Siemiński, prof. dr hab. n. med.
- Recruiting
Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice
Katowice, 40-635
Anna Lis, dr med., +48 600 198 608, lis.anna.agn@icloud.com
Mateusz Majewski, dr n. med.
Italy1 site, 1 recruiting
- Recruiting
Pineta Grande Hospital
Castel Volturno, CE, 81030
Dorotea Cerbarano, +39-0823-854111, dorotea.cerbarano@pinetagrande.it
Adriana Modestina Conte, MD
About this study
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)
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?
Read more
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
Read the 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.
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Being tested
- Temnographic Brain Screening Examination
- Keywords
- Head Trauma, Temnography, TES, Brain Injury, Brain lesion, Emergency Department
- Medical subject headings
- Brain Concussion, Craniocerebral Trauma, Brain Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temnographic Brain Screening ExaminationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| TES HT100 Examination | Experimental | 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. Receives: Diagnostic Test: Temnographic Brain Screening Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
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.
Measured: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT
Rate of device-related adverse events
Incidence and type of adverse events related to the use of TES HT100 during the study.
Measured: From TES HT100 examination through study participation completion, an average of 1 year
Secondary outcomes (4)
Operator time associated with TES HT100-supported screening
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.
Measured: Day 1
Procedures associated with TES HT100-supported screening
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.
Measured: Day 1
Costs associated with TES HT100-supported screening
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.
Measured: Day 1
Diagnostic performance of TES HT100 in predefined patient subgroups
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.
Measured: At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start4 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, prospective, multicenter, open-label diagnostic validation study in which all participants undergo standard clinical care plus an add-on TES HT100 examination, with head CT used as the reference standard.
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B&B srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabrizio Alfieri, Study director, B&B srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490418
- Sponsor's protocol ID
- CLV-01-TES HT
- Acronym
- TESCO
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 39659448Islam 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.
PubMed 34759284Gabriel 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.
PubMed 8938025Gabriel 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.
PubMed 8938024Lefevre-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.
PubMed 32387427Mckee AC, Daneshvar DH. The neuropathology of traumatic brain injury. Handb Clin Neurol. 2015;127:45-66. doi: 10.1016/B978-0-444-52892-6.00004-0.
PubMed 25702209Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.
PubMed 26537996Conte AM, Alfieri F, Localzo A, Russo E, Cucinotto I, Trovato A, Gualtieri R, Laccetti E, Sorbo A. 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. BMC Emerg Med. 2026 Jul 7. doi: 10.1186/s12873-026-01676-8. Online ahead of print.
PubMed 42414903
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07490418
- Acronym / sponsor ID
- TESCO / CLV-01-TES HT
- Conditions
- Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
- Keywords
- Head Trauma, Temnography, TES, Brain Injury, Brain lesion, Emergency Department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- B&B srlIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, prospective, multicenter, open-label diagnostic validation study in which all participants undergo standard clinical care plus an add-on TES HT100 examination, with head CT used as the reference standard.
| Arm | Type | Receives |
|---|---|---|
| TES HT100 Examination | Experimental | Diagnostic Test: Temnographic Brain Screening ExaminationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temnographic Brain Screening ExaminationA 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. | Diagnostic test | TES HT100 Examination |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Results publicationCuccaro A, et al. Microwave Radar Imaging as a Tool for Medical Diagnostics. Eng Proc. 2023.
- Results publicationSolimene R, et al. An Incoherent Radar Imaging System for Medical Applications. IEEE CAMA 2021.
- Results publicationVaia 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.
- Results publication: PubMed 39659448Montemerani 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.
- Results publication: PubMed 34759284Islam 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.
- Results publication: PubMed 8938025Gabriel 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.
- Results publication: PubMed 8938024Gabriel 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.
- Results publication: PubMed 32387427Lefevre-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.
- Results publication: PubMed 25702209Mckee AC, Daneshvar DH. The neuropathology of traumatic brain injury. Handb Clin Neurol. 2015;127:45-66. doi: 10.1016/B978-0-444-52892-6.00004-0.
- Results publication: PubMed 26537996Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.
- Derived from this study: PubMed 42414903Conte AM, Alfieri F, Localzo A, Russo E, Cucinotto I, Trovato A, Gualtieri R, Laccetti E, Sorbo A. 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. BMC Emerg Med. 2026 Jul 7. doi: 10.1186/s12873-026-01676-8. Online ahead of print.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrizio Alfieri study director
B&B srl
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temnographic Brain Screening Examination in people with Mild Traumatic Brain Injury and Intracranial Lesions, run by B&B srl at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Alfieri (+39-081-19189806, fabrizio.alfieri@temnography.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07490418, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.