Role of Non invasive Modalities in detecting intracranial haemorrhage and its radiological correlation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Sensitivity, Specificity, Accuracy and other parameters of CEREBO in determining presence or absence of an intracranial bleed
研究概览
简要总结
This clinical study will evaluate the efficacy of the non-invasive device, CEREBO, in detecting intracranial hemorrhage in patients with traumatic brain injury. The performance of CEREBO will be benchmarked against the gold standard, CT scans. This research aims to demonstrate CEREBO’s capability to identify intracranial hemorrhage at a presymptomatic stage, thereby enabling earlier detection and facilitating prompt intervention. Furthermore, the study will assess the potential reduction in unnecessary CT scans and associated radiation exposure, with a particular focus on vulnerable populations such as infants and pregnant women.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with suspected TBI referred for head CT/MRI scan.
排除标准
- •Patients with scalp bruises and hematoma.
结局指标
主要结局
Sensitivity, Specificity, Accuracy and other parameters of CEREBO in determining presence or absence of an intracranial bleed
时间窗: 3 years
次要结局
- 1. To assess the number of referrals that CEREBO could have prevented from other sites to the study site(2. To assess the usability of CEREBO® among healthcare professionals through survey questionnaires)
研究者
Dr Hansa Rot
Wockhardt Hospitals, Rajkot