Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Device ability to detect the absence of blood
研究概览
简要总结
The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.
详细描述
A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.
Subjects were followed-up for capsule passing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 -60 years
- •Ability to give written informed consent
排除标准
- •Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)
- •Known current stenosis of the GI tract
- •Presence of pacemaker or other implantable electronic device
- •Dysphagia or difficulties in swallowing pills the size of the capsule
- •History of achalasia or known esophageal dysmotility
- •History of gastroparesis
- •History of severe constipation (1 bowel movement per week or less)
- •Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
- •Active psychological issues preventing participation
- •Stomach bezoar
- •History of severe esophagitis
- •History of Crohn disease
- •History of diverticulitis
- •History of bowel obstruction
- •Suspected gastrointestinal tumor disease
- •Planned MRI investigation (MRI needed before the capsule is excreted)
结局指标
主要结局
Device ability to detect the absence of blood
时间窗: within 30 minutes
Number of subjects in which PillSense capsule was able to identify the absence of blood post capsule ingestion and transmit the results to PillSense Receiver
Device ability to detect the presence of blood
时间窗: within 30 minutes
Number of subjects in which PillSense Capsule was able to identify the presence of blood post ingestion of a mixture containing autologous blood and transmit the results to PillSense Receiver
次要结局
- Ability to ingest the capsule(within 30 minutes)
- Absence of device-related adverse event(up to 4 weeks)