Microwave Imaging in NeuroTrauma (MINT) - a Feasibility Study Investigating Whether Microwave-based Scanning Technology Can Detect an Intra-cranial Bleed in Adult Head Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Accuracy of the MD100
研究概览
简要总结
The study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head.
The MD100 is a microwave-based head scanner, developed for the purpose of detecting strokes. In clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. It was believed that this device had wider applications in trauma care.
The MD100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. The device is supported by software that determines the presence of a bleed.
This study will be set in the emergency department of major trauma centres. Patients that have sustained a head injury will be considered for enrollment into the study. Following a head CT scan, patients will be scanned by the MD100. The trial will run in two phases.
In phase one: the findings from the patient's head CT scan will be used to trial the device and teach the software what it is scanning. In phase two: The MD100 will be tested to see whether it can concur with the findings of the patient's CT scan, this will be used to determine the accuracy and reliability of the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients 18 and over.
- •Blunt head trauma
- •The patient has had a CT head scan
排除标准
- •Patients with head injuries penetrating the skull
- •Patients with radiologically confirmed cervical spine fracture
- •Patients with radiologically confirmed depressed skull fracture and/or dislocation
- •Patients with implanted metal in or around their skull (including titanium places and surgical staples)
- •Confirmed pregnancy
- •Per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial.
结局指标
主要结局
Accuracy of the MD100
时间窗: One year
The MD100's proportion of true positives of intracranial bleeds detected in the head injured patient.
次要结局
未报告次要终点
