Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Device: Upper Gastrointestinal Monitoring System

• Registration Number: NCT03680950
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2018-10-12
• Primary Completion: 2020-03-12
• Study Completion: 2020-04-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper Gastrointestinal Monitoring System	Upper Gastrointestinal Monitoring System	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.	3 days	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.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan