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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •spatial disorientation and/or loss of balance
- •speech disturbance and/or facial hemi-paresis
- •visual alterations
- •memory loss and/or confusional state
排除标准
- •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
结局指标
主要结局
Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
时间窗: 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
时间窗: 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.
次要结局
- Operator time associated with TES HT100-supported screening(Day 1)
- Procedures associated with TES HT100-supported screening(Day 1)
- Costs associated with TES HT100-supported screening(Day 1)
- Diagnostic performance of TES HT100 in predefined patient subgroups(At the index emergency department visit, with TES HT100 performed within 24 hours before or after head CT)