Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Device feasibility
研究概览
简要总结
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).
详细描述
The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".
All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".
The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 -80 years
- •Ability to give written informed consent
- •Clinical suspicion of bleeding
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
- •Subject is using a pacemaker or other implantable electrical 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)
- •Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
- •Presence of psychological issues preventing participation
- •Stomach bezoar
- •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 feasibility
时间窗: within 30 minutes
Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver
次要结局
- Safety(up to 3 weeks)
- Device Specificity(within 2 hours)
- Device sensitivity(within 2 hours)