Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

Conditions
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Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Device: Upper Gastrointestinal Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rockall score ≧3 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper Gastrointestinal Monitoring System<br>Participants who meet criteria of enrollment and is willing to join in this study will wear a real-time upper gastrointestinal monitoring system for checking whether upper gastrointestinal rebleeding occurs continuously for 3 days. | Device: Upper Gastrointestinal Monitoring System<br>* Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index. | 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index. | The accuracy of the current monitoring index and the real-time upper gastrointestinal monitoring system is compared. The accuracy is estimated by calculating the ratio of the number of making false alarm and the number of finding re-bleeding right. | 3 days |