Presence or Absence of Blood in the GI Lumen - Correlating a HemoPill Acute Measurement With a Subsequent Endoscopic Finding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants With True Positive Results
研究概览
简要总结
Bleedings in the upper digestive tract are common. Usually, laboratory and clinical parameters are considered to establish a suspicion for a bleeding in the digestive tract and to estimate urgency of the situation. If these parameters suggest the presence of a bleeding in the digestive tract, endoscopies are often performed to further investigate a patient's status. The above-mentioned laboratory and clinical parameters are sometimes not specific enough to reliably identify a bleeding in the upper digestive tract. The HemoPill acute is capsule device, that has a built in sensor that detects blood in the upper digestive tract. This information is valuable for the medical personnel and complements the information that is obtained from other laboratory or clinical tests
详细描述
The purpose of the study was to access safety and accuracy of Hemopill and its receiver. Patients scheduled for endoscopy on the basis of suspected UGIB are generally eligible for inclusion into the trial. After patient screening, information and obtaining informed consent, a patient is enrolled into the trial. Shortly before the scheduled endoscopy is performed, the patient ingests a HemoPill acute. Endoscopy is performed as scheduled. Blood within the GI lumen is identified if present and pictures are taken. Pathologies, if found, are treated as per clinical standard. The HemoPill acute measurement regarding presence or absence of blood in the GI lumen is compared to observations made during endoscopy.
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
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled for endoscopy due to suspicion of UGIB based on clinical and / or laboratory findings
- •Signed informed consent
- •Age ≥ 18 years
- •Willingness and ability to participate in the study procedure
排除标准
- •Contraindications to the use of the HemoPill acute, such as:
- •Known gastrointestinal obstruction, stricture, fistula, or diverticula
- •Dysphagia or other swallowing disorders
- •Pregnancy
- •Incapacity to provide informed consent
- •In patients with cardiac pacemakers and other implanted medical devices
结局指标
主要结局
Number of Participants With True Positive Results
时间窗: 1 hour after endoscopy procedure
HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen
Number of Participants With False Positive Results
时间窗: 1 hour after endoscopy procedure
HemoPill acute measurement positive; Endoscopy measurement negative. HemoPill acute measurement indicates presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen.
Count of Participants With True Negative Results
时间窗: 1 hour after endoscopy procedure
HemoPill acute measurement negative; Endoscopy measurement negative. HemoPill acute measurement does not indicate presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen in quantities \> 20 mL; Minimum latency of 20 minutes achieved.
Count of Participants With False Negative Results
时间窗: 1 hour after endoscopy procedure
HemoPill acute measurement negative; Endoscopy measurement positive. HemoPill acute measurement does not indicate presence of blood in the GI lumen; Endoscopy identifies fresh blood or hematin in the GI lumen in quantities \> 20 mL; minimum latency of 20 minutes achieved.
次要结局
未报告次要终点