Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

National Cheng-Kung University

Status: Completed

Conditions: Upper Gastrointestinal Bleeding

Treatments: Device: Upper Gastrointestinal Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT03680950

B-BR-106-096

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Upper Gastrointestinal Monitoring System

Experimental group

Description:

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.

Treatment:

Device: Upper Gastrointestinal Monitoring System