A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Area under the ROC curve
研究概览
简要总结
It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and oesophago-gastro-duodenoscopy (OGD).
详细描述
It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and oesophago-gastro-duodenoscopy (OGD).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible if:
- •They have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, history of hematemesis);
- •They will undergo OGD within 24 hours;
- •Written consent obtained.
排除标准
- •Subjects will be excluded from the study if they have any of the followings:
- •Contraindications for OGD (e.g. respiratory failure, suspected perforation);
- •Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness);
- •Cardiac pacemaker or implanted electromedical devices;
- •History of gastrectomy or bowel resection;
- •Active ongoing fresh hematemesis;
- •Unstable hemodynamics despite adequate resuscitation;
- •Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
- •Pregnancy.
研究组 & 干预措施
Hemopill
HemoPill® acute capsule (Ovesco Endoscopy, Tuebingen, Germany) is a swallowable, wireless, sensor capsule designed for in vivo detection of liquid blood or hematin. The capsule has integrated optical microsensor for blood detection, by transmitting red and violet light via LEDs. It allows the detection of blood by photometric measuring method, in small volumes or in unprepared digestive tract. The dimensions of the capsules are 7.0mm x 26.3mm. The maximal examination time is 9 hours. The HemoPill® receiver is a portable receiver for displaying and storing measured values from the HemoPill® acute capsule. It allows a real-time, wireless, telemetric data transmission. Once activated, the HemoPill® acute capsule can be swallowed by patients with real-time measurement of HemoPill® Indicator (HI). An HI value in the red range suggests a positive finding - liquid blood or hematin has been detected.
干预措施: Hemopill (Device)
结局指标
主要结局
Area under the ROC curve
时间窗: duration of study, 2 hours
The primary endpoint is the area-under-the-ROC curve (AUC) for HemoPill® capsule, which is defined by the true positive and false positive rates of HI signals.
次要结局
- Negative predictive value(duration of study, 2 hours)
- Adverse event rate(duration of study, 2 hours)
- Positive predictive value(duration of study, 2 hours)
- Technical success rate(duration of study, 2 hours)
- Time to a positive HI signal(duration of study, 2 hours)
- Sensitivity(duration of study, 2 hours)
- Specificity(duration of study, 2 hours)
- Time to OGD from Hemopill capsule examination(duration of study, 2 hours)
研究者
Louis Ho Shing Lau
Assistant Professor
Chinese University of Hong Kong