Клиническая валидация TES HT100 для скрининга травм головного мозга у пациентов с легкой черепно-мозговой травмой или неврологическими симптомами (TESCO)
Клинические исходы TES HT100 - Клиническая валидация теннографа TES HT100 для скрининга черепно-мозговой травмы у пациентов с легкой травмой головы или подозрением на неврологические симптомы (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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Fabrizio Alfieri
- Номер телефона: +39-081-19189806
- Электронная почта: fabrizio.alfieri@temnography.com
Места учебы
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CE
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Castel Volturno, CE, Италия, 81030
- Рекрутинг
- Pineta Grande Hospital
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Контакт:
- Dorotea Cerbarano
- Номер телефона: +39-0823-854111
- Электронная почта: dorotea.cerbarano@pinetagrande.it
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Младший исследователь:
- Angelo Localzo, Registered Nurse
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Младший исследователь:
- Esaù Russo, Registered Nurse
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Главный следователь:
- Adriana Modestina Conte, MD
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Младший исследователь:
- Antonia Sorbo, MD - Radiologist
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Gdansk, Польша, 80-952
- Еще не набирают
- Emergency Department, University Clinical Centre, Medical University of Gdańsk
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Контакт:
- Paweł Nowicki
- Номер телефона: +48 730 505 991
- Электронная почта: nowicki.p@wp.pl
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Главный следователь:
- Mariusz Siemiński, prof. dr hab. n. med.
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Katowice, Польша, 40-635
- Рекрутинг
- Emergency Department, Leszek Giec Upper Silesian Medical Centre of the Medical University of Silesia in Katowice
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Контакт:
- Anna Lis, dr med.
- Номер телефона: +48 600 198 608
- Электронная почта: lis.anna.agn@icloud.com
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Главный следователь:
- Mateusz Majewski, dr n. med.
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Operator time associated with TES HT100-supported screening
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Fabrizio Alfieri, B&B srl
Публикации и полезные ссылки
Общие публикации
- Brazinova 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.
- 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.
- Islam MS, Islam MT, Almutairi AF. Experimental tissue mimicking human head phantom for estimation of stroke using IC-CF-DMAS algorithm in microwave based imaging system. Sci Rep. 2021 Nov 10;11(1):22015. doi: 10.1038/s41598-021-01486-x.
- Gabriel S, Lau RW, Gabriel C. The dielectric properties of biological tissues: II. Measurements in the frequency range 10 Hz to 20 GHz. Phys Med Biol. 1996 Nov;41(11):2251-69. doi: 10.1088/0031-9155/41/11/002.
- Gabriel C, Gabriel S, Corthout E. The dielectric properties of biological tissues: I. Literature survey. Phys Med Biol. 1996 Nov;41(11):2231-49. doi: 10.1088/0031-9155/41/11/001.
- Lefevre-Dognin C, Cogne M, Perdrieau V, Granger A, Heslot C, Azouvi P. Definition and epidemiology of mild traumatic brain injury. Neurochirurgie. 2021 May;67(3):218-221. doi: 10.1016/j.neuchi.2020.02.002. Epub 2020 May 6.
- Mckee 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.
- Conte 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Повреждения головного мозга, травматические
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Раны и травмы
- Патологические процессы
- Атрибуты болезни
- Травма, нервная система
- Травмы головы, закрытые
- Раны, Непроникающие
- Патологические состояния, признаки и симптомы
- Чрезвычайные ситуации
- Травмы головного мозга
- Сотрясение мозга
- Черепно-мозговая травма
Другие идентификационные номера исследования
- CLV-01-TES HT
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .