Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680950
• Other study ID #: B-BR-106-096
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 30, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• Upper Gastrointestinal Monitoring System
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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