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临床试验/NCT03680950
NCT03680950已完成不适用

Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.

研究概览

简要总结

A monitoring system was developed for detecting upper gastrointestinal (UGI) rebleeding. This system consists of (1) a tiny endoscopy, (2) a wearable device, and (3) a software. The endoscopy is inserted to UGI tract via nasal cavity and then stayed there for 3 days. The wearable device is set to regularly receive the pictures from the endoscopy and sent to the software, which is able to automatically analyze whether the rebleeding occurs. This study aims to test the feasibility and efficacy of the monitoring system.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • "Rockall" score ≧3

排除标准

  • Pregnant woman;
  • Behavioral disorder;
  • Major cognitive-perceptual deficit;
  • The person who has a nasogastric (NG) tube;
  • Other deficits or disorders that are not suitable for NG insertion;
  • Participants who need to take MRI scan.

结局指标

主要结局

Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.

时间窗: 3 days

The real-time upper gastrointestinal monitoring system is compared with the current monitoring index. The efficacy is estimated by which monitoring method finding the upper gastrointestinal rebleeding first.

次要结局

  • The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.(3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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